Z-0421-2007

Desktop Pro R6.0 & R6.1, Linear Medical Accelerator

Name: Z-0421-2007 Desktop Pro R6.0 & R6.1, Linear Medical Accelerator
Creator: Elekta, Inc.
Published: 2006-11-23
License: https://open.fda.gov/license/

Elekta Limited / initiated 2006-11-23 / Terminated / root cause: software

FDA source

Elekta, Inc. began a recall of Desktop Pro R6.0 & R6.1, Linear Medical Accelerator on 2006-11-23. The reason FDA records is "Unexpected Diaphragm movement when manual field size modifications are not saved". 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-0421-2007
Status: Terminated
Initiated: 2006-11-23
Posted: 2007-02-07
Terminated: 2008-05-14
Recalling firm: Elekta Limited
Product: Desktop Pro R6.0 & R6.1, Linear Medical Accelerator.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Unexpected Diaphragm movement when manual field size modifications are not saved.
Root cause tag: software
FDA root cause: Software design
Action: Consignees were notified by letter on/about 11/23/2006
Quantity in commerce: 37 units
Distribution: Worldwide distribution ---- including USA states of AZ, AL, CA, CO, FL, GA, IA, MI, NV, OH, OK, PA, WA, WV and Country of Canada .
Product codes and lots: Model number MRT 9871/ MRT 10601 (This issue affects Desktop Pro 6.0 and 6.1 users with a 3rd party R & V System, with the exception of Sigma Micro Users)

Product code IYE

K982713Class IIRt DesktopElekta Oncology Systems, Ltd. / cleared 1998-11-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)