Discovery recallZ-0606-2019 · GE Healthcare, LLC · initiated May 24, 2018
Completed
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Healthcare, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.
FDA root cause category: Component change control
What the company is doing
The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.
Recall details
- Recall number
- Z-0606-2019
- Status
- Completed
- Initiated by the company
- May 24, 2018
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 4 units
- Product code
- KPS
- FDA submissions
- K093514
- Distribution
- CA, DC, OH, UT, WI, Canada
Product description
Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
Code information (models, lots, serial numbers)
GTIN 00840682124393 Serial Numbers: DDRW34032, DDRX34038, DDRX34041, DDRX34045
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Discovery 670 DRG E Medical Systems Israel Ltd. · System, x-ray, tomography, computed2 recalls0 reports
Product lines
Other devices under the same FDA submission
5 devices cleared under K093514 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Discovery 670 PRO H3100AHG E Medical Systems Israel Ltd. · System, tomography, computed, emission2 recalls0 reports
- Discovery 670 ES H3100AGG E Medical Systems Israel Ltd. · System, tomography, computed, emission1 recall0 reports
- Discovery NMCT 670 ESG E Medical Systems Israel Ltd. · System, x-ray, tomography, computed1 recall0 reports
- Discovery 670 DRG E Medical Systems Israel Ltd. · System, tomography, computed, emission1 recall0 reports
- NMCT 870 DRG E Medical Systems Israel Ltd. · System, x-ray, tomography, computed1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 81680).
- Z-0607-2019 · CompletedDiscovery NM/CT 670 ES, model 5376204-70-57
- Z-0608-2019 · CompletedDiscovery NM/CT 670 Pro, model 5376204-70-54
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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