FDAClass IIJuly 18, 2012

MOSAIQ Oncology Information Systems interfaced to recall

MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology…

Why was MOSAIQ Oncology Information Systems interfaced to 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Version 2.10 - all builds and version 2.20 - builds up to and including 2.20.07A7.

Product
MOSAIQ Oncology Information Systems interfaced to Elekta Treatment machines. An image enabled electronic medical record system used for oncology…
Recalling firm
Impac Medical Systems Inc
Quantity
11 affected sites
Distribution
Worldwide Distribution -- USA, including the states of VA, CT, GA, NJ and NY and the countries of Belgium, Denmark, France, and the United Kingdom.
Recall date
July 18, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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