—#165576

Product

Discovery MI Digital Ready

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K133657
Affected lot / code info: Model Number 5986030. a. Serial Number PTDMI1800003PT, System ID Number RADNETPT1839, UDI Number 01008406821209751118010421PTDMI1800003PT; b. Serial Number PTDMI1800005PT, System ID Number RADNETPT1838, UDI Number 01008406821209751118010421PTDMI1800003PT; c. Serial Number PTDMI1800009PT, System ID Number 813745DMIDR2, UDI Number 01008406821209751118021921PTDMI1800009PT

Why it was recalled

DIGITAL ReadyCT/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 #165576. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.