GE Medical Systems 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa recall — FDA Z-3027-2017
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
27,577 detailed records are currently available in this category.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Baxter Healthcare Corporation has been made aware that users may not be following the instructions in the Operators Manual and incorrectly (using sharp objects) opening disposable set…
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Manufacturing process used to assemble the circuit board may result in some devices experiencing a faster than expected reduction in device longevity.
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
The device can deliver an atypical amount of energy due to memory corruption inside the device.
The Truliant Tibial Trial Handle's pin may disassociate from the main body.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay…
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
LeadCare II Test Kits controls out of range
Dryer unit not heating. Manufacturing issue causes the terminal block to overheat, char and/or burn.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
Insufficient documentation to support product sterility claims.
Devices are not consistent with Quality System Requirements.
Insufficient documentation to support product sterility claims.
Devices are not consistent with Quality System Requirements.
Devices are not consistent with Quality System Requirements.
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