FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
- Recall number
- Z-2174-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
- Status
- Terminated
- Initiated
- 2014-05-28
- Posted
- 2014-08-10
- Terminated
- 2015-07-23
- Reason
- A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
- Root cause
- Use error
- Action
- An Urgent Medical Device Correction Field Safety Notice Letter was sent to end users on/about June 2014 which described the product, problem, and actions to be taken to avoid encountering the safety risk to patients and users.
- Quantity
- 160
- Distribution
- Nationwide and ROW, including Canada and Mexico.
- Lot, serial or model codes
- material numbers: 01940035, 04504200, 05672977, 05693908, 05857912, 05857920, 08139789, 08319758, 08490005, 08515520, 09401654, 09401746, 09822693, with serial numbers below 3094.
- 510(k) numbers
- ["K031764","K072485","K790688","K982502"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- 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