Siemens brand ARTISTE MV with Artiste Digital Linear Accelerators in combination with the Flat Panel Positioner; Part No
FDA device recall Z-1422-2011 · posted 2011-02-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc., Concord, CA
- Reason for recall
- The firm become aware of a potential issue with ARTISTE system that may result in patient injury should the positioner belt break, and the cam disc (secondary safety mechanism) is not installed and if the flat panel is over the patient.
- Action taken
- The firm, Siemens, issued a "Customer Information" letter on December 3, 2010 via mail to all its direct consignees/customers. The letter described the product, problem and actions taken by the firm to the customer. Siemens arranged for an inspection of their customers systems to make sure the safety mechanism is fully functional. Siemens instructed the customers to include the Customer Information letter in their ARTISTE System Owner manual chapter 'Safety Advisory Letters' . If you any questions, please call 925-246-8407.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 20 units
- Distribution
- Worldwide distribution.
- Date initiated
- 2010-12-03
- Date posted
- 2011-02-24
- Date terminated
- 2011-06-30
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |