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FDA device recall Z-1627-2023 · posted 2023-05-27 · Open, Classified
Recall details
- Recalling firm
- Trophy SAS
- Reason for recall
- Device failed to function as intended and/or failed to conform to their design specifications.
- Action taken
- The letter identified the affected product, problem and actions to be taken.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OAS
- Quantity affected
- 895 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2021-07-21
- Date posted
- 2023-05-27
- Location
- Marne, France
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CS 9600 (K200183) | Trophy | 2020-03-13 |
| CS 9600 (K181136) | Trophy | 2018-05-24 |