Sequencer Verify & Record System, for use with radiotherapy treatment machines, Class IIb, manufactured by Impac Medical Systems, Sunnyvale, CA.
FDA Recall Z-0076-2011 · Posted 2010-10-18
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Recalling FirmImpac Medical Systems Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2010-09-02
Date Terminated2011-06-24
Product Quantity797 units
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.
Firm 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
Root Cause
Software design
Distribution Pattern
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.
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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