Recall Z-1494-2012 ยท IYE Accelerator, Linear, Medical
Siemens Medical Solutions USA, Inc
Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR Expression 7360717, ONCOR Impression Plus 5857912, ONCOR Avant Garde 5863472, PRIMUS HI 4504200; ARTISTE/ONCOR/PRIMUS systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, Roentgenstrasse 19-21, Kemnath, GERMANY 95478 Product Usage: Medical charged-particle radiatio
| Date | May 8, 2012 (initiated Apr 4, 2012) |
| Status | Terminated |
| Reason | The firm became aware of a potential issue with Siemens-branded ONCOR or PRIMUS linear accelerator with an OPTIVUE or MVision imaging system that has the potential collision problem of the imaging panel if the panel does not retract before the gantry rotates; this may result in patient injury. |
| Root cause | Process control |
| Action | Siemens sent an Update Instruction containing the Customer Information letters beginning April 4, 2012 delivered by Siemens customer Service Group or by certified mail to all affected customers. The letter identified the affected product, what is the issue and what has Siemens done to address this issue. The letter instructs customer to include this Customer Information in their Digital Linear Accelerator System Owner Manual chapter Safety Advisory Letters where it should remain. |
| Quantity | 73 units |
| Distribution | Worldwide Distribution - USA Nationwide |
| FDA record | Open on fda.gov |