FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.
- Recall number
- Z-0437-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.
- Status
- Terminated
- Initiated
- 2013-10-23
- Posted
- 2013-12-03
- Terminated
- 2014-01-22
- Reason
- A safety risk regarding a potentially existing dark current radiation phenomenon on the Linear Accelerator (LINAC) in combination with IMRT or mARC (rotational IMRT) treatments using unflat (flattening filter free) beams. In case there are many long periods of field shape changes in a treatment plan, the dose due to dark current radiation may sum up to a significant value.
- Root cause
- Device Design
- Action
- Siemens sent an Urgent Medical Device Correction letter dated October 23, 2013 including the release of update instruction TH024/13/S to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer.
- Quantity
- 3 units
- Distribution
- Worldwide Distribution: USA (nationwide) including states of: FL, NC, NY, PA, TN, UT, and WI; and countries of: Angola, Brazil, Canada, P.R. China, Germany, India, Japan, Republic Korea, Poland, and Thailand.
- Lot, serial or model codes
- Serial Numbers: 5281, 5385, 5445
- 510(k) numbers
- ["K060226"]
- 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