—#165578

Product

Discovery RT labeled as: a. MID BJG; b. HVY BJG

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K132410
Affected lot / code info: 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)

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 #165578. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.