GE Healthcare Recalls NM/CT 860 Scanners Due to Radiation Exposure Shift
GE Healthcare is recalling NM/CT 860 scanners because a specific protocol may cause a 5cm shift in radiation exposure, potentially requiring patient re-scans.
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 risk-of-harm product (radiation exposure shift) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
GE Healthcare, LLC is recalling NM/CT 860 Nuclear Medicine / CT Scanners due to a potential issue that could cause a shift in the CT radiation exposure range. The shift can be up to 5cm compared to the intended radiation exposure range for the planned scan. This issue occurs only on a hybrid whole-body continuous F3 protocol with Zoom < 1 where the scan range is set on the Smart Console.
In some cases, this discrepancy may necessitate a re-scan of the patient. A re-scan would expose the patient to additional X-ray radiation. The recall involves 242 units in total, with 17 units distributed in the United States. The distribution pattern is worldwide, with US nationwide distribution.
The source text does not specify specific actions for consumers or patients beyond the identification of the affected units and the potential for re-scanning. Healthcare facilities should verify if their units are affected based on the specific workflow conditions described.
The recalled product
- Product
- NM/CT 860 Nuclear Medicine / CT Scanners
- Manufacturer
- GE Healthcare, LLC
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 (1)
- GTIN*00840682140751
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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