Reported Jul 18, 2012 · Terminated
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record…
Impac Medical Systems Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Impac Medical Systems Inc · 100 Mathilda Place · Sunnyvale, CA · 94086-6076
Is this the product you have?
- 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 Place5th floor SunnyvaleCa 94086
- Lot codes and dates
- Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.
- Amount recalled
- 11 affected sites
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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