FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions, Concord, CA
- Recall number
- Z-0449-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens brand ARTISTE MV, Artiste Digital Linear Accelerators in combination with the Flat Panel, Part No. 8139789, To deliver x-ray radiation for therapeutic treatment of cancer. Product is manufactured and distributed by Siemens Medical Solutions, Concord, CA
- Status
- Terminated
- Initiated
- 2010-01-22
- Posted
- 2010-11-24
- Terminated
- 2011-04-12
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 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 Turkey
- Lot, serial or model codes
- All units--Dates of manufacture: July 17, 2008 to September 19, 2008.
- 510(k) numbers
- ["K072485"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Martinez
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28