Z-1546-2021 Class II Ongoing
FDA device recall Z-1546-2021 was initiated by GE Healthcare, LLC on February 7, 2021 and is designated Class II. Reason for recall: 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 rang… The recall status is ongoing. Affected quantity: 242 in total (17 units US).
Recall Details
- Product Type
- Devices
- Report Date
- May 19, 2021
- Initiation Date
- February 7, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 242 in total (17 units US)
Product Description
NM/CT 860 Nuclear Medicine / CT Scanners
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide
Code Information
GTIN*00840682140751