Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
All Recalls
95,114 total recalls in our database
Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
CareFusion 303
🏥 Medical Devices Class I - Dangerous
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.
SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
American Contract Systems Hand Pack convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.
American Contract Systems Biopsy Drape Pack convenience kit
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
🏥 Medical Devices Class I - Dangerous
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Precision Surgical Table due to a potential issue with loose spring pins in the spindle drives. This can cause the tabletop to unexpectedly tilt or move at any time, even without active use of the surgical table. This could potentially result in unintentional patient movement during surgical procedures and/or preparation for surgical procedures, including transport.
🏥 Medical Devices Class I - Dangerous
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
🏥 Medical Devices Class I - Dangerous
Specific lots of TruDi NAV Suction Instruments 0 Degrees were incorrectly calibrated which when used with the TruDi Navigation System, may result in a discrepancy between the actual tip location and the visualized location displayed on the system.
🏥 Medical Devices Class I - Dangerous
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
🏥 Medical Devices Class I - Dangerous
Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Mmonitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient,
Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions are met: 1. 2D FSE T2 FLAIR OR T2 FLAIR Propeller imaging sequence is selected, AND 2. the Optimized T2 FLAIR sequence option is turned off OR not included in the MR configuration. If this occurs, it can result in overheating of an MR conditional implant.
🏥 Medical Devices Class I - Dangerous
Due to software issue, there is a potential when a restock label is printed for a medication stored in automated dispensing cabinets, that the incorrect bin for the medication is printed on the label.