Z-2581-2018Class II
Discovery RT labeled as: a. MID BJG; b. HVY BJG
GE Healthcare / initiated 2018-05-24 / Terminated
GE Healthcare, LLC began a recall of Discovery RT labeled as: a. MID BJG; b. HVY BJG 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-2581-2018
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- GE Healthcare
- Product
- Discovery RT labeled as: a. MID BJG; b. HVY BJG
- 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
- Model Number 2374682-17. a. MID BJG. Serial Number CBCIG1800017HM (System ID 847695CTRT, UDI 01008406821186991118020021CBCIG1800017HM), Serial Number CBCIG1700070HM (System ID 251665MCIRT, UDI 01008406821186991117120021CBCIG1700070HM), Serial Number CBCIG1700064HM (System ID 973831RT, UDI 01008406821186991117120021CBCIG1700064HM), Serial Number CBCIG1800001HM (System ID 708747RT590, UDI 01008406821186991118010021CBCIG1800001HM); b. HVY BJG. Serial Number CBCIG1700062HM (System ID 904819RTCT, UDI 01008406821186991117120021CBCIG1700062HM), Serial Number CBCIG1700040HM (System ID 843692GSOCT, UDI 01008406821186991117100021CBCIG1700040HM)
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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