FDAClass IIJuly 22, 2015

MOSAIQ Oncology Information System MOSAIQ is an recall

MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports…

Why was MOSAIQ Oncology Information System MOSAIQ is an recalled?

A problem exists in MOSAIQ resulting in the incorrect field size being sent to the treatment machine for stereotactic plans using cones.

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?

Software Version 2.41 and higher

Product
MOSAIQ Oncology Information System MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery. It supports…
Recalling firm
Elekta, Inc.
Quantity
74 Total (45 US)
Distribution
Worldwide Distribution - US including AZ, CA, GA, ID, IL, MO, NJ, NY, NC, OR, SC, TN, WV, and Internationally to Austria, Brazil, Bulgaria, Canada, Colombia, Germany, Israel, Italy, Japan, Mexico, Russia, Taiwan, and Venezuela.
Recall date
July 22, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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