Z-0076-2011

Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by...

Name: Z-0076-2011 Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by...
Creator: Impac Medical Systems Inc
Published: 2010-09-02
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-09-02 / Terminated / root cause: software

FDA source

Impac Medical Systems Inc began a recall of Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA on 2010-09-02. The reason FDA records is "Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient". 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-0076-2011
Status: Terminated
Initiated: 2010-09-02
Posted: 2010-10-18
Terminated: 2011-06-24
Recalling firm: Elekta Limited
Product: Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Software issue-- matching criteria can be configured that permits an invalid patient match, resulting in overwriting of patient records with information from a different patient.
Root cause tag: software
FDA root cause: Software design
Action: Elekta Impac Software issued a Important Safety Notice letter dated September 2010 to all customers identifying the software issue and clinical impact. Customer Support representatives will contact each site and modify site configuration or upgrade existing software to the version containing the corrective fix. Customers can contact Impac Software at 800 488-4672
Quantity in commerce: 797 units
Distribution: Worldwide Distribution: throughout the US and the countries of Australia, Austria, Belgium, Canada, China, Hong Kong, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Jordan, Morocco, Netherlands, New Zealand, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, and UK.
Product codes and lots: All sequencers for all M/A and MOSAIQ builds..

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)