510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
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
FDA enforcement reports joined to recall event Z-2581-2018
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2578-2018Class IITerminatedVoluntary: Firm initiated
Z-2579-2018Class IITerminatedVoluntary: Firm initiated
Z-2580-2018Class IITerminatedVoluntary: Firm initiated
Z-2581-2018Class IITerminatedVoluntary: Firm initiated
Z-2582-2018Class IITerminatedVoluntary: Firm initiated
Z-2583-2018Class IITerminatedVoluntary: Firm initiated
Z-2584-2018Class IITerminatedVoluntary: Firm initiated
Z-2585-2018Class IITerminatedVoluntary: Firm initiated
Z-2586-2018Class IITerminatedVoluntary: Firm initiated
Z-2587-2018Class IITerminatedVoluntary: Firm initiated