Z-2444-2012Class II

SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka...

Name: Z-2444-2012 SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka...
Creator: Raysearch Laboratories Ab
Published: 2011-10-10
License: https://open.fda.gov/license/

RaySearch Laboratories AB (publ) / initiated 2011-10-10 / Terminated / root cause: labeling and UDI

FDA source

RAYSEARCH LABORATORIES AB began a recall of SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy)... on 2011-10-10. FDA classified it as Class II and gives the reason as "This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2444-2012
Classification: Class II
Status: Terminated
Initiated: 2011-10-10
Posted: 2012-09-24
Terminated: 2013-01-25
Recalling firm: RaySearch Laboratories AB (publ)
Product: SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists.
Product code: MUJ System, Planning, Radiation Therapy Treatment
Reason for recall: This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. This behavior has not caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivered treatment. The behavior appears, when importing RFA-files (.asc)
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: RaySearch Laboratories sent an Urgent Field Safety Notice Medical Device Correction letter dated October 10, 2011, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. To completely avoid effects of the erroneous behaviour, RFA-file has to be modified to have the crossline profiles sgtored in the X column of the file and the inline profiles in the Y column. Upon request, RaySearch Laboratories will provide help to the customers by transferring the RFA-files to the correct format through a scrip. Customers were instructed to pass on the notice to all those who need to be aware within their organization and to maintain awareness on this notice until the new labeling version has been received to ensure effectiveness of the corrective action. For questions regarding this recall call +46 8 54 50 61 42.
Quantity in commerce: 20 units
Distribution: Worldwide Distribution - USA including CA, KY, MI, NY, OK, OR, SD, and WI. Internationalyl to Canada, Sweden, France, Germany, Australia, Poland, Belgium, and United Kingdom.
Product codes and lots: version 1.2.1 (build number 1.3.1.10).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2444-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2444-2012	Class II	Terminated	Voluntary: Firm initiated	2012-10-03	2012-09-24

Product code MUJ

K083264Class IIRayautoplan 1.0Raysearch Laboratories AB / cleared 2009-01-22

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)