FDAClass IIJuly 5, 2017

MOSAIQ(R) Oncology Information System recall

MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows…

Why was MOSAIQ(R) Oncology Information System recalled?

Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.

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?

None

Product
MOSAIQ(R) Oncology Information System, Versions 2.50.05 and higher Product Usage: MOSAIQ¿ is an oncology information system used to manage workflows…
Recalling firm
Elekta, Inc.
Quantity
355 units
Distribution
Worldwide Distribution - US Nationwide and the countries of ANTIGUA AND BARBUDA, AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, CHEZ REPUBLIC, GERMANY, HUNGARY, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, AND UK
Recall date
July 5, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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