Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, To d
FDA device recall Z-0449-2011 · posted 2010-11-24 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- The robotic lift armature shaft may break and allow the Flat Panel Positioner with the digital flat panel imager to fall into the Flat Panel cradle. If the positioner is over a patient, there is a potential for injury.
- Action taken
- Siemens sent an Urgent Medical Device Correction letter to all on January 27, 2010, via phone, Fax, certified mail and/or delivery via Siemens Customer Service Group to all its direct consignees, informing them of the affected products, the problem, and provided instructions on the recall. Consigneees were to be contacted by an ARTISTE Service Representative for an appointment for corrective action. Consignees were instructed to include Customer Safety Advisory Notice in their ARTISTE System Owner Manual. For questions regarding this recall call (925) 246-8407.
- Root cause
- Other
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 106
- Distribution
- Worldwide Distribution - USA including CA, DE, FL, LA, MA, MI, MO, NC, NE, NJ, OH, PA, TN, UT, WI, AND WV and Egypt, Germany, Japan, Lebanon, Malaysia, New Zealand, Poland, Russia, Spain, Sweden, and
- Date initiated
- 2010-01-22
- Date posted
- 2010-11-24
- Date terminated
- 2011-04-12
- Location
- Martinez, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTISTE MV SA (K072485) | Siemens Medical Solutions USA, Inc. | 2007-12-27 |