Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
Philips Medical Systems (Cleveland)
315 recalls • • Categories: Other Medical Devices, Diagnostic Equipment, Implants & Prosthetics
Class I - Dangerous
Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
Class I - Dangerous
When computing a radiation dose in the system, the exported dose information is incorrect when there is more than one beam attached to the prescription and certain options are selected on the Edit Prescription screen.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
An issue with the Detector for the Forte Family of cameras may result in either detector 1 or detector 2 falling unimpeded vertically to the end stops of its travel limit.
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied
Class I - Dangerous
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Class I - Dangerous
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
Class I - Dangerous
An issue with the handcontroller may result in either spontaneous uncommanded motions or continued motion after the buttons were released.
The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cover parts and/or protrusion of the cover into the bore diameter.
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
A software update is being issued to correct multiple issues identified in the previous software version.
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
Software Correction: Software errors that may result in incorrect 4D CT images, PET images with SUV quantification error, or disruption of interventional CT procedures; and Software errors that may result in partial set of images, inability to generate CT or PET images, incorrect scan parameters, or scanning the incorrect portion of the body.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
It was reported that scanners running certain software versions provide confusing information in the "Impressions" section of the Calcium Score report. The generated report provides multiple analyses of the amount of plaque detected, as if they all apply to the patient at the same time. This misleading guidance can be potentially misleading to the user, and may lead to mistreatment of the patient.
The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw may be misaligned in the patient pallet.
Class I - Dangerous
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Class I - Dangerous
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Class I - Dangerous
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Class I - Dangerous
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Class I - Dangerous
A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Class I - Dangerous
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Class I - Dangerous
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Class I - Dangerous
The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment in certain scenarios.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Surview scan with tube current lower than 30 mA is unable to be initialized.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Following a period of inactivity, the mass storage device may cause the acquisition console to become unresponsive. This may prevent an acquisition from proceeding.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Class I - Dangerous
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and the disable result rotation setting when turning on the CT simulation Exam Card; Software errors that may result in Tumor LOC allowing POI (Point of Interest) locking when a non-isocenter slice is displayed; Software errors that may result in partial set of images or inability to generate CT images.
A software issue causes PET reconstructions to fail intermittently. It was determined that reconstructions fail due to a negative table position (-1 value is inserted) in the raw data list file, rather than the actual table position. This error has been found to occur in two scenarios: 1) When the system operator cancels an acquisition a. The error will occur every time a scan is cancelled by the operator. 2) Couch position requests within the software sequence were delayed a. The error occurs intermittently, but has been found to occur more frequently when the gantry s network is heavily loaded with multiple retrospective reconstructions running in parallel. b. The error manifests to the technologist by an error message and Failed status on the Reconstruction Monitor and the error message Result {0} failed to reconstruct" on the Acquisition Workflow window during reconstruction after the patient scan has been completed. In both scenarios, the acquisition data will not be able to be reconstructed and will therefore be unusable.
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Class I - Dangerous
One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to secure the top two GSU covers, was missing mounting hardware.
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Class I - Dangerous
Numerous issues related to software Brilliance iCT 4.1.6 software version.
During collimator exchange, the alignment of the collimator cart and detectors may cause a collimator exchange fail, and a collimator may drop to the floor beside the collimator cart. The collimator may be partially supported by the cart (e.g. leaning against the cart), or it may fall/slide all the way to the floor.
Class I - Dangerous
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Class I - Dangerous
Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, data acquisition, exam stop, tube overheat, memory overflow, failure to give error message, length of acquisition, image volume and other functions.
Class I - Dangerous
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Class I - Dangerous
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Class I - Dangerous
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Class I - Dangerous
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
Class I - Dangerous
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Class I - Dangerous
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
Class I - Dangerous
There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to the scanner s main bearing may come loose. If this occurs, the part(s) will not be expelled, however, a noise may be heard coming from the gantry.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
The brake hub was not engaging with the gear box shaft due to an error in the assembly of components within the brake hub mechanism after service, causing the detector to backdrive.
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door interlock switch problem disables CT scan. 3. Detector contacts head holder when performing Patient Unload. 4. JETStream freezes during gated planar scan
Class I - Dangerous
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Class I - Dangerous
The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.
Class I - Dangerous
During a retrospective review of production documentation it was observed that the M6 Rotor Counterweight Bolt may have been improperly torqued.
Failure to correctly document the installation of four M12 Bolts into the system rotor.