Device product
Optima NM/CT 640, Model number 3101RL - Product Usage: intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Z-0858-2021
Product summary
- Event
- Event 87023
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-0858-2021
Official wording
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.
Code information: Serial Numbers: 64GY51017, 64GY51020, 64GY51022, 64GZ51028, 64GZ51030, 64GZ51029, 64GY51021
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
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.