GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Reported: January 20, 2021 Initiated: December 10, 2020 #Z-0854-2021
Product Description
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Reason for Recall
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.
Details
- Recalling Firm
- GE Healthcare, LLC
- Units Affected
- 12 units
- Distribution
- Worldwide
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
GE NM/CT 860 system Model Number H3908AD - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.. Recalled by GE Healthcare, LLC. Units affected: 12 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2021. Severity: Moderate. Recall number: Z-0854-2021.
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