Siemens-branded ONCOR" or PRIMUS" linear accelerator with an OPTIVUE" or MVision" imaging system; Model Numbers: ONCOR E
FDA device recall Z-1494-2012 · posted 2012-05-08 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 73 units
- Distribution
- Worldwide Distribution - USA Nationwide
- Date initiated
- 2012-04-04
- Date posted
- 2012-05-08
- Date terminated
- 2012-09-17
- Location
- Concord, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |