GE Healthcare Recalls Optima NM/CT 640 Due to Loose Rotor Bearing Screws
GE Healthcare is recalling seven Optima NM/CT 640 units because loose rotor bearing screws caused a bearing release in one field unit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a mechanical defect (loose screws leading to bearing release) but explicitly does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling seven units of the Optima NM/CT 640, Model number 3101RL. This medical device is intended for general nuclear medicine imaging procedures to detect radioisotope tracer uptake in the patient body. The recall covers units with specific serial numbers distributed worldwide.
The recall was initiated after GE Healthcare became aware that rotor bearing screws were found loose on one detector in the field. This mechanical issue led to the release of one of the four rotor bearings in the detector. The source text does not report any patient injuries or illnesses associated with this defect.
Healthcare facilities should contact GE Healthcare for instructions on how to address the affected units. The recall is classified as Class II by the FDA, indicating a situation where use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- 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.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 7
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Serial Numbers: 64GY51017
- 64GY51020
- 64GY51022
- 64GZ51028
- 64GZ51030
- 64GZ51029
- 64GY51021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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