GE Healthcare, LLC began a recall of Optima CT 520 on . FDA classified it as Class II and gives the reason as "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)". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-2585-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- Product
- Optima CT 520
- Product code
- JAK System, X-Ray, Tomography, Computed
- Reason for recall
- 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).
- FDA root cause
- Component change control
- Action
- GE Healthcare notified customers on about 05/24/2018 via URGENT MEDICAL DEVICE CORRECTION letter. The letter outlined the reason for recall and notified customers that a GE Healthcare representative would be contacting them to arrange for the correction of the devices. Any questions or concerns can be directed to GE Healthcare Service at 1-800-437-1171 or a local Service Representative.
- Quantity in commerce
- 42 units total
- Distribution
- Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
- Product codes and lots
- Serial number, CBCRG1700051HM, System ID Number 580622O520, UDI Number 01008406821025681117120021CBCRG1700051HM
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2578-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2579-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2580-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2581-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2582-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2583-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2584-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2585-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2586-2018 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2587-2018 | Class II | Terminated | Voluntary: Firm initiated |
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