FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
- Recall number
- Z-1308-2014
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software
- Status
- Terminated
- Initiated
- 2014-02-06
- Posted
- 2014-03-31
- Terminated
- 2017-02-17
- Reason
- RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy.
- Root cause
- Software Design Change
- Action
- On February 6, 2014, RaySearch Laboratories distributed Urgent Medical Device Correction notices to their customers via email regarding the affected product. To determine if the version you are using is affected, bring up the About box in the RayStation application and check if the number reported is "4.0.2.9". If so, the notice applies to your version. Customers are advised to inform all planning staff and all users about the instructions listed on the notice. Customers are advised to inspect their system and identify all installed units with the referenced software version numbers listed on the notice. Corrective labeling is distributed to the customers in the form of the safety notification attached to this report and the software problem will be resolved in RayStation patch 4.0.3 scheduled for market release end of February 2014 and in all future releases. For further information and return of the reply form, please contact: Freddie Cardel, Director of Customer Support, RaySearch Americas, (877) 778-3849 or freddie.cardel@raysearchlabs.com.
- Quantity
- 19 units (16 units domestically & 3 units internationally)
- Distribution
- OH, MD, NJ, WA, IL, MA, FL, Spain, United Kingdom, Italy,
- Lot, serial or model codes
- Model#: 4.30; Version: 4.0.2.9; 3D-CRT optimization or Fallback Planning Licenses
- 510(k) numbers
- ["K130617"]
- 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