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.
FDA Recall Z-1029-2011 · Posted 2011-02-04
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Recalling FirmImpac Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-03-10
Date Terminated2011-04-06
Product Quantity40
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution -- US, Canada, Germany, and France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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