Z-0079-2017Class II

Radiation Therapy Treatment Planning System, Model 5.0

Name: Z-0079-2017 Radiation Therapy Treatment Planning System, Model 5.0
Creator: Raysearch Laboratories Ab
Published: 2016-05-30
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2016-05-30 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of Radiation Therapy Treatment Planning System, Model 5.0 on 2016-05-30. FDA classified it as Class II and gives the reason as "For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0079-2017
Classification: Class II
Status: Terminated
Initiated: 2016-05-30
Posted: 2016-10-13
Terminated: 2017-09-22
Recalling firm: RaySearch Laboratories AB (publ)
Product: Radiation Therapy Treatment Planning System, Model 5.0
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
Root cause tag: software
FDA root cause: Software design
Action: On May 19th, 2016, RaySearch Laboratories distributed Field Safety Notice, Medical Device Correction notices and reply forms to their customers via email. Actions to be taken by the customer include: 1) Inspect all report templates that are intended to be used for plans with multiple beam sets. 2) Make sure that POI Dose statistics (Plan) is included immediately before ROI Dose statistics [Plan dose] in the Report content area. 3) Please educate planning staff and all users about this workaround. 4) Inspect your product and identify all installed units with the above software version number. Finally, complete and return the reply form via email to: [email protected] or by fax to: 888-501-7195 to confirm that you have read and understand the information. Customers with questions can contact David Hedfors via email: [email protected]
Quantity in commerce: 491 units (187 domestically & 304 internationally)
Distribution: AZ, CA, FL, MT, NC NY, TX, OH & WA
Product codes and lots: 5.0.0.37, 5.0.1.11 and 5.0.2.35

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0079-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0079-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code MUJ

K160093Class IIRayStationRaySearch Laboratories AB (PUBL) / cleared 2016-04-08

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)