FDA (Devices) recall action 80484
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
Some CT and CT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
DIGITAL ReadyCT/PET systems recently installed with a GE supplied A! electrical panel may not be properly wired to the partial system UPS (Uninteruptible Power Supply).
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
GE Healthcare is recalling 42 Revolution EVO 3.6 CT systems installed with a specific electrical panel that may not be properly wired to the UPS.
GE Healthcare is recalling 42 CT Goldseal Optima CT 600 systems because they may not be properly wired to the uninterruptible power supply.
GE Healthcare is recalling 42 Revolution CT 160 systems because they may not be properly wired to the uninterruptible power supply.
GE Healthcare is recalling 42 Discovery MI Digital Ready CT/PET systems because they may not be properly wired to the uninterruptible power supply.
GE Healthcare is recalling 42 Discovery RT CT systems nationwide due to a potential wiring defect in the electrical panel that may affect the uninterruptible power supply.
GE Healthcare is recalling 42 CT and CT/PET systems installed with a specific electrical panel that may not be properly wired to the uninterruptible power supply.
GE Healthcare is recalling 42 Optima CT 520 units because they may not be properly wired to the uninterruptible power supply.
GE Healthcare is recalling 42 Optima CT 540 units because they may not be properly wired to the uninterruptible power supply.
GE Healthcare is recalling 42 Discovery MI CT systems installed with a specific electrical panel that may not be properly wired to the UPS.
GE Healthcare is recalling 42 Discovery IQ 2.0 CT systems installed with a specific electrical panel that may not be properly wired to the uninterruptible power supply.