FDAClass IIOctober 6, 2021

MOSAIQ Oncology Information System recall

MOSAIQ Oncology Information System

Why was MOSAIQ Oncology Information System recalled?

A drug strength in MOSAIQ can be changed during the ordering process and approved, but the saved drug strength reverts to the original value.

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?

MOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

Product
MOSAIQ Oncology Information System
Recalling firm
Elekta, Inc.
Quantity
31
Distribution
Distribution was made to CA, CO, FL, ID, LA, MO, MS, NC, NH, NM, NV, NY, OH, OK, PA, SD, and WA. There was no military/government distribution. Foreign distribution was made to Australia, Canada, and the United Kingdom.
Recall date
October 6, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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