GE Healthcare Recalls NM/CT 860 SPECT/CT Systems Due to Loose Screws
GE Healthcare is recalling four NM/CT 860 SPECT/CT systems because rotor bearing screws were found loose on the detector.
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 structural defect (loose screws) in a medical device where injury has not yet been reported, fitting the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare, LLC is recalling four units of the NM/CT 860, SPECT/CT medical imaging systems. The recall was initiated after rotor bearing screws were found loose on the detector of the affected devices.
The affected units are distributed across 29 U.S. states and 27 countries internationally. Specific serial numbers and system IDs for the four units are listed in the official recall documentation. The source text does not specify the exact nature of the risk associated with the loose screws, nor does it report any injuries or illnesses resulting from this defect.
Healthcare facilities and users of these specific systems should contact GE Healthcare for instructions on how to address the issue. The source text does not provide specific consumer action steps beyond the identification of the affected serial numbers.
The recalled product
- Product
- NM/CT 860, SPECT/CT
- Manufacturer
- GE Healthcare, LLC
- Hazard
- Affected units
- 4
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 (9)
- Serial # 850X61003
- System ID: 401793860NM
- Model # H3908AD Serial # 860X62001
- System ID:E6843969
- Model # H3908AE Serial # 870X64005
- System ID:HC4387NU05
- Model # H3100AS Serial # 860X62002
- System ID:PL0399NM01
- Model # H3100AS
Distribution
Part of a larger recall action
This product is one of 8 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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