—#165585

Product

Optima CT 540

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082816
Affected lot / code info: Serial number 500925HM3, System ID Number 615320OPT

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 #165585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.