FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com Designed for treatment planning and analysis of radiation therapy.
- Recall number
- Z-1317-2012
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation Version 2.0.0.15, Radiation Therapy Treatment Planning System. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com Designed for treatment planning and analysis of radiation therapy.
- Status
- Terminated
- Initiated
- 2011-12-06
- Posted
- 2012-03-26
- Terminated
- 2012-05-11
- Reason
- An issue was found with the dose calculation in the RayStation 2.0, that could result in a potential overestimation of the dose. This could lead to the potential under-dosage of a patient.
- Root cause
- Device Design
- Action
- The firm decided to recall and sent Urgent Field Safety Notice Medical Device Correction letters to consignees on 12/06/2011. The letters described the issue, identified the affected product, actions to be taken by the user, a solution, and contact information. Users are to follow the two part workaround, and educate their staff and all users on the workarounds. The letter states that the issue will be resolved in the next version of RayStation. If further information is needed, users are to contact either Freddie Cardel, Director of Customer Support, RaySearch Americas, at 1-877-778-3849 or freddie.cardel@raysearchlabs.com; or Niclas Borglund, Director of Service, RaySearch Laboratories AB, at 46-8-5450-6130 or niclas.borglund@raysearchlabs.com
- Quantity
- 21 units (16 domestically and 5 internationally)
- Distribution
- Worldwide Distribution -- US, including the states of FL, MA, NJ, and NY and the country of the Netherlands.
- Lot, serial or model codes
- Software version and build number is 2.0.0.15. Model number RayStation 2.0
- 510(k) numbers
- ["K100552"]
- PMA numbers
- not on file
- Product code
- MUJ
- Firm FEI
- 3007774465
- Firm city
- Stockholm
- Firm state
- not on file
- Firm country
- Sweden
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