FDA Medical Device Recalls (openFDA)
RAYSEARCH LABORATORIES AB: RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Recall number
- Z-2352-2020
- Recalling firm
- RAYSEARCH LABORATORIES AB
- Product
- RayStation 6 Service Pack 1, UDI #s 07350002010037, 07350002010082 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.
- Status
- Terminated
- Initiated
- 2020-05-18
- Posted
- not on file
- Terminated
- 2021-08-06
- Reason
- Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.
- Root cause
- Software design
- Action
- On May 18, 2020, RaySearch Laboratories emailed an Urgent Field Safety Notice, Medical Device Correction #60564 letter to their customers. The letter listed the following actions to be taken by the users: always use the MC dose engine for final dose calculation, in robustness analysis, and dose tracking if possible (the MC dose engine is available in versions RayStation 6.0 and later); if the pencil beam dose engine is used for final dose calculation, ensure that all spots intersect the External ROI as seen in the Beams Eye View (BEV) of the Plan optimization module; if they do not, expand the External ROI so that all spots do intersect the External ROI, and re-optimize the plan if necessary; if the MC dose engine is used for final dose calculation, and hot spots related to tangential fields are observed, expand the External ROI so that the central axis of all spots intersect the External ROI and re-optimize the plan; educate planning staff and all users about this workaround; inspect your product and identify all installed units with the above software version number(s). RaySearch Laboratories asked all customers to confirm that they have read and understood the notice by replying to the notification email.
- Quantity
- not on file
- Distribution
- US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.
- Lot, serial or model codes
- UDI #s 07350002010037, 07350002010082 Build number: 6.1.1.2
- 510(k) numbers
- ["K190387"]
- 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