FDA Recall
Open, Classified
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Recall: Z-0855-2021
·
Initiated December 10, 2020
Recall
- Recall Number
- Z-0855-2021
- Event Number
- 87023
- Firm
- GE Healthcare, LLC
- FEI Number
- 2126677
- Product Code
- KPS
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- December 10, 2020
- Address
- 3000 N Grandview Blvd, Waukesha, WI, 53188-1615
Description
GE NM/CT 870 CZT system Model Number H3906CW - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Reason
GE Healthcare has become aware that rotor bearing screws were found loose on one detector in the field, leading to the release of one of the four rotor bearings in the detector.
Action
The firm initiated their action by letter to the consignees on 12/10/2020. The letter explained the issue and stated that GE would inspect, and if required, correct the affected units. Questions and concerns may be directed to GE Healthcare Service at 1-800-437-1171 or the consignee's local Service Representative.
Distribution
Worldwide
Quantity
12 units