FDAClass IIAugust 3, 2016

MOSAIQ Oncology Information System recall

MOSAIQ Oncology Information System

Why was MOSAIQ Oncology Information System recalled?

It is possible that a change to an Order Set will not be saved in the current open Care Plan. This can result in a wrong chemo dose in the order.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Versions 2.50.05 and higher

Product
MOSAIQ Oncology Information System
Recalling firm
Elekta, Inc.
Quantity
383
Distribution
Worldwide distribution. US nationwide, Antigua and Barbuda, Australia, Austria, Bahamas, Bahrain, Canada, Czech Republic, Germany, Hungary, South Africa, Spain, Sweden, Turkey, and United Kingdom
Recall date
August 3, 2016
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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