GE Healthcare, LLC Recall 87811
Description: NM/CT 860 Nuclear Medicine / CT Scanners
GE Healthcare, LLC Recall 87811 Information
| Status | Ongoing |
| Mandated? | FDA Mandated |
| Recall Number | Z-1546-2021 |
| Event ID | 87811 |
| Event Description | NM/CT 860 Nuclear Medicine / CT Scanners |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide |
| Quantity | 242 in total (17 units US) |
| Recall Reason | 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. |
| Device Classification | 20210519 |
| Device Code Info | GTIN*00840682140751 |
| Center Classification Date | 20210511 |
| Recall Initiation Date | 20210207 |
| Recalling Firm | GE Healthcare, LLC |
| Initial Notification | Letter |
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