Z-1029-2011

SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in...

Name: Z-1029-2011 SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in...
Creator: Impac Medical Systems Inc
Published: 2010-03-10
License: https://open.fda.gov/license/

Elekta Limited / initiated 2010-03-10 / Terminated / root cause: software

FDA source

Impac Medical Systems Inc began a recall of SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a... on 2010-03-10. The reason FDA records is "Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field". 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-1029-2011
Status: Terminated
Initiated: 2010-03-10
Posted: 2011-02-04
Terminated: 2011-04-06
Recalling firm: Elekta Limited
Product: SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: Computer interface is defected. Computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
Root cause tag: software
FDA root cause: Software design
Action: A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email [email protected] or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer's organization.
Quantity in commerce: 40
Distribution: Worldwide Distribution -- US, Canada, Germany, and France.
Product codes and lots: Sequencer for MOSAIQ versions: 1.20, 1.30 ; 1.50 , 1.60 and 2.00, interfacing to an Elekta SL 75-5 Linacs.

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)