FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
- Recall number
- Z-0281-2014
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0
- Status
- Terminated
- Initiated
- 2013-10-23
- Posted
- 2013-11-14
- Terminated
- 2017-02-17
- Reason
- Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.
- Root cause
- Software design
- Action
- Medical Device Correction Letters dated 10/23/13 were e-mailed to the user accounts on 10/23/13.
- Quantity
- 195 units domestically
- Distribution
- US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.
- Lot, serial or model codes
- Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.
- 510(k) numbers
- ["K120387","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