Artiste MV Digital Linear Accelerator System Equipped with 160 MCL Accessory Holder, Manufactured by Siemens Medical Sol
FDA device recall Z-0949-2009 · posted 2009-01-30 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The range of tolerance is to high for the accessory holder, therefore, Wedges and other accessories do not latch to the locking mechanism correctly.
- Action taken
- On 12/20/08, the firm issued letters via certified mail to direct consignees, informing them of the affected product and providing instructions on the recall. Contact Siemens Medical Solutions USA, Inc. at 1-925-246-8407 for additional information.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 43 units
- Distribution
- Nationwide and Worldwide
- Date initiated
- 2008-12-20
- Date posted
- 2009-01-30
- Date terminated
- 2010-12-09
- 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 |