Z-2426-2020Class II

RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all...

Name: Z-2426-2020 RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all...
Creator: Raysearch Laboratories Ab
Published: 2020-05-26
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2020-05-26 / Open, Classified

FDA source

RAYSEARCH LABORATORIES AB began a recall of RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2 on 2020-05-26. FDA classified it as Class II and gives the reason as "It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2426-2020
Classification: Class II
Status: Open, Classified
Initiated: 2020-05-26
Posted: 2020-06-24
Recalling firm: RaySearch Laboratories AB (publ)
Product: RayStation standalone software treatment planning system (RayStation 8A, 8B, 9A, and 9B, including all service packs) model no. 8.0, 8.1, 9.0, 9.1, 9.2
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: It is not obvious that the manual import of a treatment record into RayCare PACS does not automatically import the same data into RayTreat. In addition, there is an issue found with the display of planned and recorded Gantry Angle in the delivered beam list in RayTreat.
FDA root cause: Under Investigation by firm
Action: On May 26, 2020, the firm notified affected customers of the product issue via emailed Field Safety Notices. Customers were made aware of the following issues: 1) When only a single beam record is received for a specific beam, the delivered Gantry angle is hidden and only the planned Gantry angle is shown, and 2) For users of RayCare 3B and RayStation RayTreat 9B (including all service packs), if a manual import is necessary, the treatment record must be imported manually into both RayStation and PACS. ACTIONS TO BE TAKEN BY THE USER " Be aware that the Gantry angle column in the first row for each beam in the Beam delivery results always shows the planned Gantry angle and does not indicate which Gantry angle was used when delivering a beam. " If treatment records are not successfully sent from the delivery machine to RayTreat: o always manually record all the beams that were delivered before signing off the session. o import all treatment records into both RayStation and RayPACS. " Take extra precautions when delivering a continuation session based on a manually recorded or offline imported treatment records to ensure that the correct amount of radiation is delivered during the continuation. " Educate treatment staff and all users about this workaround. " Inspect your product and identify all installed units with the above software version number(s). " Confirm you have read and understood this notice by replying to the notification email. The firm plans to resolve these issues in the next version of RayStation, which the firm estimates will be available in June 2020. If customers wish to continue using versions of RayStation affected by this notice, all users must maintain awareness of this notice. Alternatively, customers can choose to upgrade to the new version once it becomes available for clinical use.
Quantity in commerce: 12
Distribution: Distributed to one consignee in Nashville. Foreign distribution to one consignee in Belgium.
Product codes and lots: Software versions 8.0.0.61 , 8.0.1.10 , 8.1.0.47 , 8.1.1.8 , 8.1.2.5 , 9.0.0.113 , 9.1.0.933 and 9.2.0.483

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2426-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2426-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-01	2020-06-24

Product code MUJ

K190387Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2019-06-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)