ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solut
FDA device recall Z-0459-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Reports of gantry rotation without receiving a movement command caused by an overload within the drive signal power line.
- Action taken
- Siemens Medical Solutions USA, Inc. sent a Customer Information letter dated November 9, 2011, by federal express. The letter identified the product the problem and the action needed to be taken by the customer. The HW Update included information regarding the potential problem and provide instructions in the Safety update. Further questions call (925) 602-8157.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 13 active devices
- Distribution
- Worldwide Distribution-- USA ( nationwide ) including the states of : MO, NC, OH, and OK and the countries of Turkey, Japan, Germany and Portugal
- Date initiated
- 2011-11-09
- Date posted
- 2012-01-11
- Date terminated
- 2013-04-15
- 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 |
|---|---|---|
| ALTUM ANTERIOR CERVICAL PLATE (K103505) | Spinecraft, LLC | 2011-03-15 |
| ONCOR EXPRESSION (K060226) | Siemens Medical Solutions USA, Inc. | 2006-03-15 |