Z-1481-2014Class II

RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5...

Name: Z-1481-2014 RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5...
Creator: Raysearch Laboratories Ab
Published: 2014-02-14
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2014-02-14 / Terminated / root cause: software

FDA source

RAYSEARCH LABORATORIES AB began a recall of RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0 on 2014-02-14. FDA classified it as Class II and gives the reason as "RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image". 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-1481-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-14
Posted: 2014-04-21
Terminated: 2017-02-15
Recalling firm: RaySearch Laboratories AB (publ)
Product: RaySearch Ray Station Radiation Therapy Treatment Planning System, Stand-alone software. Versions 2.0, 2.5, 3.0, 3.5 and 4.0.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: RaySearch Laboratories has recalled "RaySearch Ray Station 2.0, 2.5, 3.0, 3.5 and 4.0" software due to dose miscalculations for bolus/external/fixation support structures on CT-image.
Root cause tag: software
FDA root cause: Software design
Action: RaySearch Laboratories sent a Field Safety Notice, Medical Device Correction letter dated February 14, 2014 to their customers via email. The letter identified the affected product, problem and actions to be taken by the user. Customers with questions may contact Freddie Cardel, Director of Customer Support at 1-877-778-3849 or via email at [email protected].
Quantity in commerce: 251 units (148 units domestically & 103 units internationally)
Distribution: Worldwide Distribution - USA Nationwide in the states of: AZ, CA, CT, CO, DE, FL, IL, NJ, NY, MA, MD, MS, OH, PA, TN, VA and WA. and the countries of Australia, New Zealand, Belgium, New South Wales, Republic of Korea, Italy, Germany, China, France, Switzerland, Netherlands, Spain, Austria, United Kingdom and Norway.
Product codes and lots: Versions: 2.0.0.15, 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1481-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1481-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-21

Product code MUJ

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)