Recall Z-1486-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens-branded linear accelerator with a 550 TxT Treatment Table with a serial number <_ 1894. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478. Product Usage: The intended use of the SIEMENS branded ARTISTE, ONCOR and PRIMUS family of linear
| Date | May 3, 2012 (initiated Apr 3, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | 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 Digita |
| Quantity | 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, Egypt, France, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malays |
| FDA record | Open on fda.gov |