Class I - Dangerous
Customers may experience an issue with the software study preferences when changes are made to the study protocol, resulting in incorrect patient follow-up.
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Diagnostic Equipment
🏥 Medical Devices • 6,627 recalls
Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
Skintact Electrodes for Defibrillation, DF29N. Product Usage: Multifunction electrode for external defibrillation, pacing, cardioversion, and monitoring. The device is non-sterile and for single use only.
Leonhard Lang Medizintechnik GmbH
Class I - Dangerous
There is a risk that defibrillation electrodes model DF29N will be connected with the defibrillator Welch Allyn AED 10 only with delay or not at all. This may cause a situation in which a patient, who is in a life threatening condition and requires a defibrillation shock, cannot be treated in good time.
Class I - Dangerous
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Fujifilm Synapse PACS, Software versions: 4.0.xxx, 4.1.xxx, version 4.2.xxx, version 4.3.xxx Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Fujifilm Medical Systems U.S.A.
Class I - Dangerous
Image data for a patients image may not be correct
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Class I - Dangerous
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Class I - Dangerous
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
Class I - Dangerous
A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.
Toshiba America Medical Systems, Inc . Aquilion RXL TSX-101 A/R, U CT Scanner Diagnostic imaging systems indicated to acquire and display cross sectional volumes of the whole body, to include the head.
Toshiba American Medical Systems
Class I - Dangerous
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Toshiba America Medical Systems, Inc Aquilion Lightning TSX-035A CT Scanner.
Toshiba American Medical Systems
Class I - Dangerous
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range sub-therapeutic, therapeutic, and supra-therapeutic could be affected.
TriFoillmaging Triumph/Triumph II Research CT scanners.
Northridge Tri-Modality Imaging,
Class I - Dangerous
The Firm has determined that several Triumph/Triumph II Research CT scanners produced by Northridge Trimodality Imaging, inc dba TriFoillmaging (or by Gamma Medica-Ideas, Inc and field upgraded with a replacement x-ray tube) may be out of compliance with 21 CFR 1020.40 (Cabinet X-ray standards)
Toshiba America Medical Systems, Inc . Aquilion LB TSX-201A/2, 3 CT Scanner
Toshiba American Medical Systems
Class I - Dangerous
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.
Toshiba America Medical Systems, Inc . Celesteion PCA-9000A/2 CT Scanner
Toshiba American Medical Systems
Class I - Dangerous
It has been found that if the scan range extends beyond the maximum Field of View (FOV), a reconstruction operation error may occur. As a result, scanning may be interrupted and rebooting of the system may be necessary. Please note that this issue has not occurred in the U.S.