FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
- Recall number
- Z-0857-2009
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artiste MV Digital Linear Accelerator, when used in combination with Syngo RT Therapist Version 4.1 build 67 and automatic Motion of Flat Panel, part number 8139789, manufactured by Siemens Medical Solutions, Oncology Care System. Intended use is to deliver x-ray radiation for therapeutic treatment of cancer.
- Status
- Terminated
- Initiated
- 2008-10-23
- Posted
- 2009-01-14
- Terminated
- 2010-12-09
- Reason
- Under certain conditions, the flat panel may move unexpectedly and collide with the patient.
- Root cause
- Labeling design
- Action
- The firm issued an Urgent Medical Device Customer Safety Letter, dated 10/23/2008. With the letter included a detailed description of the issue, the condition under which this issue may occur, and recommendation to avoid them. Customers are to read the information carefully and distribute to the responsible persons. The Customer Safety Letter should be included their syngo RT Therapist Express manual and remain there until the next release of software is installed. In the interest of safety, the preventive measures should be performed and all affected personnel should be informed immediately. The firm is tracking responses via return cards and completion protocol.
- Quantity
- 31 consignees have the configuration noted above.
- Distribution
- Worldwide Distribution --- including USA and countries of Netherlands, Germany, Poland, Norway, Australia, Belgium, France, New Zealand, Malaysia, Spain and Canada.
- Lot, serial or model codes
- Part # 8139789, with Syngo RT Therapist version 4.1 build 67
- 510(k) numbers
- ["K072485"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 2937457
- Firm city
- Concord
- 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