GE Healthcare Recalls Discovery NM 630 and 830 Nuclear Medicine Cameras
GE Healthcare is recalling 81 Discovery NM 630 and 830 units due to loose rotor bearing screws that could release a bearing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a mechanical defect in a medical device where a component released in the field, representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 81 units of Discovery NM 630, NM 830, and 830 NM Cyber Defense nuclear medicine imaging systems. The recall was initiated after loose rotor bearing screws were found on one detector in the field, which led to the release of one of the four rotor bearings in that detector.
The affected products are intended for general Nuclear Medicine imaging procedures for the detection of radioisotope tracer uptake in the patient body. The units were distributed worldwide. Specific model numbers and serial numbers are listed in the agency's recall record.
No injuries or illnesses have been reported in connection with this recall. Consumers and healthcare facilities should contact GE Healthcare for instructions on how to address the defect.
The recalled product
- Product
- Discovery NM 630 (Model Number H3101RH), NM 830 (Model Number H3910AC), 830 NM Cyber Defense (Model Number H3910AG) - 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
- 81
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 (20)
- Discovery NM 630 (Model Number H3101RH)
- Serial numbers: 63GY50110
- 63GY50119
- 63GY50116
- 63GZ50141
- 63GY50120
- 63GY50108
- 63GY50121
- 63GZ50142
- 63GY50112
- 63GZ50139
- 63GY50107
- 63GZ50138 NM 830 (Model Number H3910AC)
- Serial Numbers: 830Z60199
- 830Z60182
- 830Z60183
- 830Z60192
- 830Y60089
- 830Y60105
- 830Y60079
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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