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 Place
    • 5th floor Sunnyvale
    • Ca 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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 19, 2013 · Data as of Sep 19, 5:24 PM UTC

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