Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
FDA device recall Z-0242-2022 · posted 2021-11-24 · Open, Classified
Recall details
- Recalling firm
- GE Healthcare, LLC
- Reason for recall
- The accumulated dose is incorrectly displayed in certain situations. Thisoccurs during an interventional exam using the SmartStep option if the table height is adjusted after the exam starts. In this situation, the SmartStep display will show a value that is higher (up to 100 times) than the actual dose delivered.
- Action taken
- GE sent an Important Electronic Product Radiation Warning Notification letter dated October 4, 2021 to customers, The letter identified the affected product, problem and actions to be taken. Customers were informed that 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 Service at 1-800-437-1171 or your local Service Representative.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- JAK
- Quantity affected
- 105 in total
- Distribution
- Worldwide and US Nationwide Distribution
- Date initiated
- 2021-06-30
- Date posted
- 2021-11-24
- 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 |
| REVOLUTION CT (K133705) | Ge Medical Systems, LLC | 2014-04-11 |