Siemens brand PRIMUS Linear Accelerators equipped with the optional Retractable Beam Shield and MEVATRON Linear Accelera
FDA device recall Z-0355-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Incomplete installation of the optional Beam Shield may allow unexpected doses of radiation outside the radiation protected areas.
- Action taken
- On 1/8/03, the firm initiated the recall and its notification was via letters informing its customers of the corrective action.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 125 units
- Distribution
- 28 units shipped within the US, 97 shipped internationally, to countries including Japan, India, Taiwan, Hungary, Italy, France, Colombia, Germany, Austria, CAnada, Croatia, Poland, Croatia, Brazil, T
- Date initiated
- 2003-01-08
- Date posted
- 2006-01-06
- Date terminated
- 2006-05-15
- 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 |
|---|---|---|
| PRIMUS (K993425) | Siemens Medical Solutions USA, Inc. | 1999-11-26 |