PlainRecordsFDA · Medical device recall
Revolution Apex… and 1 more product
- Date
- April 13, 2022
- 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
- The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
- Distribution pattern
- Worldwide - US Nationwide distribution.
2 products in this recall
Revolution Apex…
- Product
- Revolution Apex, Revolution CT with Apex Edition
- Quantity
- 273 (51 US, 222 OUS) in total
- Codes and lots
- Revolution Apex, Revolution CT with Apex Edition
- Recall started
- June 30, 2021
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.
- Recall number
- Z-0815-2022
Revolution CT…
- Product
- Revolution CT, Revolution CT ES
- Quantity
- 273 (51 US; 222 OUS) in total
- Codes and lots
- Revolution CT, Revolution CT ES
- Recall started
- June 30, 2021
- Device type
- System, X-Ray, Tomography, Computed
- Root cause (FDA)
- Radiation Control for Health and Safety Act
- What the company told customers
- GE Healthcare sent an Important Electronic Product Radiation Warning letter dated February 8, 2022 to all affected systems informing its users of the potential for the issue to occur and instruct the users as to what actions to take. GE Healthcare will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you or through a GE Healthcare field engineer site visit. For questions contact GE Healthcare Services at 1 (800) 437-1171 or local Service Representative.
- Recall number
- Z-0816-2022
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0815-2022, Z-0816-2022. The agency record governs; check it and the company before acting.