GE Healthcare Recalls NM/CT 850 Scanners Due to Radiation Exposure Shift
GE Healthcare is recalling NM/CT 850 scanners because a specific workflow may cause a 5cm shift in CT radiation exposure, potentially requiring patient re-scans.
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 involves a risk-of-harm product (radiation exposure shift) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare, LLC is recalling NM/CT 850 Nuclear Medicine / CT Scanners. The recall involves 242 units in total, with 17 units distributed in the United States. The devices were distributed worldwide, including nationwide in the US.
The recall is due to a potential issue where the CT radiation exposure range may shift by up to 5cm compared to the intended range under specific workflows. 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 shift may necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation. The source text does not report any illnesses, injuries, or deaths associated with this issue.
The recalled product
- Product
- NM/CT 850 Nuclear Medicine / CT Scanners
- Manufacturer
- GE Healthcare, LLC
- Hazard
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*00840682140775
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.
See all 3 products in this recall →Related recalls
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