Z-1515-2008

SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO...

Name: Z-1515-2008 SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO...
Creator: Impac Medical Systems Inc
Published: 2008-02-14
License: https://open.fda.gov/license/

Elekta Limited / initiated 2008-02-14 / Terminated / root cause: software

FDA source

Impac Medical Systems Inc began a recall of SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA... on 2008-02-14. The reason FDA records is "Software issue may result in change to intended treatment field, potentially resulting in mistreatment". 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-1515-2008
Status: Terminated
Initiated: 2008-02-14
Posted: 2008-08-16
Terminated: 2009-06-24
Recalling firm: Elekta Limited
Product: SEQUENCER, MOSAIQ versions 1.3 and 1.4 with Elekta and Siemens Machines, Model number 40003-001000-RO, Manufactured by IMPAC Medical Systems, Sunnyvale, CA. Used to facilitate the delivery of defined radiotherapy treatment plans.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software issue may result in change to intended treatment field, potentially resulting in mistreatment.
Root cause tag: software
FDA root cause: Software design
Action: Firm issued field advisory to its consignees on 02/14/2008. Phone calls will also be made to affected customers to ensure reception and understanding of the field notification. Firm advises users with affected product to review the jaw positions of IMRT fields to ensure that they match the RT Plan after an Apply Limits or Machine Change occurs, until software at their site can be updated to the corrected version. A software patch is under construction.
Quantity in commerce: 36 units
Distribution: Worldwide Distribution --- USA including states of OH, OK, NJ, MN, OR, TN, NY, CA, AZ, NV, IA, GA, AL, MD, MI, PA, IN, WA, FL, TX, CO, and countries to Canada, Australia, Germany, Greece and Sweden.
Product codes and lots: MOSAIQ versions 1.30 and 1.40 with Elekta iCom or Siemens DMIP

Product code IYE

K981313Class IISequencerImpac Medical Systems, Inc. / cleared 1998-07-09

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)