FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
- Recall number
- Z-0359-2012
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation Version 2.0.0.15 Consult instruction for use. RaySearch Laboratories AB Sveavagen 25, SE-111 34 Stockholm Sweden. support@raysearchlabs.com RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.
- Status
- Terminated
- Initiated
- 2011-10-19
- Posted
- 2011-12-02
- Terminated
- 2012-05-11
- Reason
- The firm has found an issue with DICOM RT Image representation of DRR images from RayStation 2.0 which needs to be clarified in the user manual. The symptoms involve the Pixel Spacing and Image Position attributes in the RT images being incorrect, thus enabling the user to make measurements that are erroneous and possibly misalign the patient.
- Root cause
- Device Design
- Action
- The firm, RaySearch Laboratories, sent an email with an "Urgent Field Safety Notice Medical Device Correction" notice dated October 19, 2011 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to pass on the information in the field safety notice to everyone involved and create routines to compensate for the incorrect DRR images; if the DICOM DRR images are not used to make any form of absolute measurements, no action needs to be taken. Raysearch laboratories will provide a script to update these DICOM files to have the correct values upon request. For further information please contact RaySearch Laboratories AB Quality and Regulatory Affairs Manager at +46 722 366 110 or david.hedfors@raysearchlabs.com; RaySearch Americas Director of Customer Support at +1 877 778 3489 or freddie.cardell@raysearchlabs.com.
- Quantity
- 19 units
- Distribution
- Worldwide distribution: USA (nationwide) including states of: MA, NJ, and NY; and country of: Netherlands
- Lot, serial or model codes
- Software version and build number is 2.0.0.15
- 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
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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