Recalls / —
—#165583
Product
Optima CT 520
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K123596
- Affected lot / code info
- Serial number, CBCRG1700051HM, System ID Number 580622O520, UDI Number 01008406821025681117120021CBCRG1700051HM
Why it was recalled
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).
Root cause (FDA determination)
Component change control
Action the firm took
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.
Recalling firm
- Firm
- GE Healthcare, LLC
- Address
- 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615
Distribution
- Distribution pattern
- Nationwide distribution to AL, CA, CO, FL, IL, IN, MA, MD, MI, MS, NC, NJ, NY,OH, OK, SC, TN, TX, VA.
Timeline
- Recall initiated
- 2018-05-24
- Terminated
- 2019-02-08
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #165583. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.