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U.S. Department of Health and Human Services

Enforcement Report - Week of July 18, 2012

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Product Detail

Product Description MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology workflow management. Manufactured by: Impac Medical Systems 100 Mathilda Place, 5th floor Sunnyvale, Ca 94086
Recall Number Z-1944-2012
Classification Class II
Code Info Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
Product Distributed Qty 11 affected sites
Reason For Recall Impac Medical became aware of a problem with the recording of the Wedge Motor Units in MOSAIQ when it resumes after a machine terminates/faults, the remaining Wedge MU was being erroneously set to zero.

Event Detail

Event Id 62302
Product Type Devices
Status Ongoing
Recalling Firm Impac Medical Systems Inc
City Sunnyvale
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-08
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.