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Other Medical Devices

🏥 Medical Devices • 15,809 recalls

Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

Getinge AGS, FSLC, FSUC, RC accessory to Washer- Disinfector 86 Series UDI Info: 86 Series Washer Disinfector 07340153700246, 07340153700253, 07340153700260, 07340153700277 Getinge automated loading/unloading systems are intended to be used as an automatic conveyor/transport system for unloading carriers (wash carts) from Getinge 86/88 series Washer-disinfectors. The automated loading/unloading systems in no way affect the cleaning/disinfection performance of the washer-disinfector. The automated loading/unloading equipment is considered an accessory to the medical washer-disinfector.

Getinge Disinfection Ab

Class I - Dangerous

There is potential for a cart with disinfected goods to unload without the trolley being docked. Disinfected goods could end up falling to the floor causing risk to nearby users and damage to goods and equipment.

Mar 2, 2018 Other Medical Devices Nationwide View Details →

Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.

Zimmer Biomet

Class I - Dangerous

There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

Mar 29, 2018 Other Medical Devices Nationwide View Details →

Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

Halyard Closed Suction System for Adults, Multi-Access¿Port¿Closed¿Suction¿System¿for¿Adults. Used to aspirate liquids or semisolids from a patient's upper airway. a. HALYARD* MULTI-PORT, DSY, ENDO 10FR; b. HALYARD* MULTI-PORT, DSY, ENDO 12FR; c. HALYARD* MULTI-PORT, DSY, ENDO, MDI 12FR; d. HALYARD* MULTI-PORT, DSY, ENDO 14FR; e. HALYARD* MULTI-PORT, DSY, TRACH 14FR; f. HALYARD* MULTI-PORT, DSY, TRACH, WP 14FR; g. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; h. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; i. HALYARD* MULTI-PORT, DSY, ENDO, WP 14FR; j. HALYARD* MULTI-PORT, DSY, ENDO, MDI 14FR; k. HALYARD* MULTI-PORT, DSY, ENDO, MDI 16FR;

Halyard Health

Class I - Dangerous

Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.

Feb 7, 2018 Other Medical Devices Nationwide View Details →

Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

GE Healthcare Lunar: a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Class I - Dangerous

Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.

Mar 16, 2018 Other Medical Devices Nationwide View Details →

Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

GE Healthcare Lunar: a) DPX Duo, Model Number: LU41693 b) DPX Bravo, Model Number: LU41692 Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Class I - Dangerous

Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS.

Mar 16, 2018 Other Medical Devices Nationwide View Details →

Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →

Brilliance 6 Slice (Air) - Model no. 728256, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

Philips Medical Systems (Cleveland)

Class I - Dangerous

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Feb 8, 2018 Other Medical Devices Nationwide View Details →
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