NM/CT 860 Nuclear Medicine / CT Scanners recall
NM/CT 860 Nuclear Medicine / CT Scanners
Why was NM/CT 860 Nuclear Medicine / CT Scanners recalled?
GE Healthcare has become aware of a potential issue on 800 family NM/CT Scanners that could cause a shift in CT radiation exposure range of up to 5cm compared to the intended radiation exposure range of the planned scan under specific workflows. The 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 may also necessitate a re-scan of the patient, which would expose the patient to additional X-ray radiation.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN*00840682140751
- Product
- NM/CT 860 Nuclear Medicine / CT Scanners
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 242 in total (17 units US)
- Distribution
- Worldwide distribution - US Nationwide
- Recall date
- May 19, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)