PlainRecordsFDA · Medical device recall
NM/CT 850 Nuclear Medicine / CT Scanners and 2 more products
- Date
- May 19, 2021
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Ongoing
- Filed by
- GE Healthcare, LLC
- 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.
- Distribution pattern
- Worldwide distribution - US Nationwide
3 products in this recall
NM/CT 850 Nuclear Medicine / CT Scanners
- Product
- NM/CT 850 Nuclear Medicine / CT Scanners
- Quantity
- 242 in total (17 units US)
- Codes and lots
- GTIN*00840682140775
- Recall started
- Feb. 7, 2021
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Device Design
- What the company told customers
- GE Healthcare will send a customer notification letter describing the issue and providing safety instructions for immediate mitigation of the issue. Customers were instructed, they may continue to use the system and follow workaround instructions (zoom=1 for specific WB protocol) until the correction is provided. GE Healthcare corrective action is the development and deployment of a software update on all affected smart console IB systems at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1545-2021
NM/CT 860 Nuclear Medicine / CT Scanners
- Product
- NM/CT 860 Nuclear Medicine / CT Scanners
- Quantity
- 242 in total (17 units US)
- Codes and lots
- GTIN*00840682140751
- Recall started
- Feb. 7, 2021
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Device Design
- What the company told customers
- GE Healthcare will send a customer notification letter describing the issue and providing safety instructions for immediate mitigation of the issue. Customers were instructed, they may continue to use the system and follow workaround instructions (zoom=1 for specific WB protocol) until the correction is provided. GE Healthcare corrective action is the development and deployment of a software update on all affected smart console IB systems at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1546-2021
NM/CT 870 DR Nuclear Medicine / CT Scanners
- Product
- NM/CT 870 DR Nuclear Medicine / CT Scanners
- Quantity
- 242 in total (17 units US)
- Codes and lots
- GTIN*00840682140836
- Recall started
- Feb. 7, 2021
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Device Design
- What the company told customers
- GE Healthcare will send a customer notification letter describing the issue and providing safety instructions for immediate mitigation of the issue. Customers were instructed, they may continue to use the system and follow workaround instructions (zoom=1 for specific WB protocol) until the correction is provided. GE Healthcare corrective action is the development and deployment of a software update on all affected smart console IB systems at no cost to the customer. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
- Recall number
- Z-1547-2021
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1545-2021, Z-1546-2021, Z-1547-2021. The agency record governs; check it and the company before acting.