Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, O
FDA device recall Z-1486-2012 · posted 2012-05-03 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- SIEMENS has received reports where a dropping down of the 550 TxT" Treatment Table was observed while the table was being moved downwards during operation by means of the hand control.
- Action taken
- Siemens sent Customer Information letters to all affected customers beginning April 3, 2012 via Siemens Field Service Engineers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter included an Update Instructions TH006/12/S - TxT Table Software Update VD00A. SIEMENS has arranged for a modification of the affected system. A SIEMENS Service Representative will ensure that the new software version VD00A is installed on affected system. The letter instructs customer to please include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 624 active devices
- Distribution
- Worldwide Distribution - USA (nationwide) including P.R and the countries of: Africa, Angola, Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia,
- Date initiated
- 2012-04-03
- Date posted
- 2012-05-03
- Date terminated
- 2013-03-14
- Location
- Concord, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE SOLUTION WITH SYS_VB50 UPDATE (K103606) | Siemens Medical Solutions USA, Inc. | 2011-04-15 |
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |