Revolution Apex, Revolution CT with Apex Edition
FDA device recall Z-0815-2022 · posted 2022-04-05 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- The accumulated dose is incorrectly displayed in certain situations. There are two situations that will result in the SmartStep displayed dose being inaccurately high.
- Action taken
- 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.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 273 (51 US, 222 OUS) in total
- Distribution
- Worldwide - US Nationwide distribution.
- Date initiated
- 2021-06-30
- Date posted
- 2022-04-05
- Location
- Waukesha, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition (K191777) | Ge Medical Systems, LLC | 2019-07-26 |
| Revolution CT (K163213) | Ge Medical Systems, LLC | 2016-12-16 |