GE Healthcare Recalls 12 NM/CT 860 Systems Due to Loose Rotor Bearing Screws
GE Healthcare is recalling 12 NM/CT 860 systems because loose rotor bearing screws caused a bearing release in one field unit.
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 is classified as FDA Class II, and the source describes a mechanical defect (bearing release) that poses a risk of harm to the device or patient, but no injuries or illnesses are reported in the text.
Plain-English summary
GE Healthcare, LLC is recalling 12 units of the GE NM/CT 860 system (Model Number H3908AD). These systems are intended for general Nuclear Medicine imaging procedures to detect radioisotope tracer uptake in the patient body.
The recall was initiated after loose rotor bearing screws were found on one detector in the field. This condition led to the release of one of the four rotor bearings in that specific detector. The affected units were distributed worldwide.
Healthcare facilities should contact GE Healthcare for instructions on how to address the issue with the affected serial numbers. The specific serial numbers involved are: 860Y62016, 860Y62019, 860Y62017, 860Z62032, 860Y62018, 860Y62015, 860Y62012, 860Y62020, 860Y62021, 860Y62013, 860Z62033, and 860Z62031.
The recalled product
- Product
- 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.
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 12
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 (12)
- Serial numbers: 860Y62016
- 860Y62019
- 860Y62017
- 860Z62032
- 860Y62018
- 860Y62015
- 860Y62012
- 860Y62020
- 860Y62021
- 860Y62013
- 860Z62033
- 860Z62031
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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