Recall Z-2639-2011 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc - Radiation Oncology
MEV ATRON PRIMART, camera imaging system, Part Number: 5500371; Product is manufactured and distributed by SIEMENS MEDICAL SOLUTIONS USA, INC. Concord, CA; and SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse, Kemnath, GERMANY, and SIEMENS AG, MEDICAL SOLUTIONS Henkestrasse, Erlangen, GERMANY The intended use of the SIEMENS branded linear accelerator systems is to deliver X-ray photon and ele
| Date | Jun 23, 2011 (initiated Nov 4, 2010) |
| Status | Terminated |
| Reason | The firm has become aware of a potential issue that may result in a service engineer receiving an electrical shock should the connector cable housing become unfastened from the chassis. |
| Root cause | Other |
| Action | The firm, SIEMENS, sent a "Customer Information" letter to its customers on November 4, 2010. The letter describes the product, problem and actions to be taken. The customers were instructed to include this letter in their BEAMVIEW TI System Owner Manual chapter "Safety Advisory Letters" where it should remain. Siemens has developed an updated kit to install an additional grounding cable on the camera's central control unit to eliminate the problem. The updated kit was delivered with the Customer Information letter. If you have any questions, contact the Service Manager- Regulatory Affairs |
| Distribution | Worldwide distribution: |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K982502 | GENESIS IMRT LINEAR ACCELERATOR Siemens Medical Solutions USA, Inc., Jul 31, 1998 |