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. |
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