CLASS II ONGOING Device recall · Reported 6 Oct 2021 · FDA Enforcement Report

Mosaiq Oncology Information System recalled by Elekta

Elekta is recalling Mosaiq Oncology Information System, distributed in 17 states. The recall was initiated on 2 Sep 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMOSAIQ 2.83 when run with First Data Bank (FDB), UDI/GTIN MOSAIQ 2.83 (0858164002367)

Quantity recalled31

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2591-2021
FDA event ID: 88599
Recalling firm: Elekta, Sunnyvale, CA
Classification: Class II
Status: Ongoing
Recall initiated: 2 Sep 2021
FDA classified: 29 Sep 2021
Reported: 6 Oct 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Medical Software

Timeline

2 Sep 2021	Recall initiated by company
29 Sep 2021	Classified by FDA	+27 days
6 Oct 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

MOSAIQ Oncology Information System

Where it was distributed

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.

California Colorado Florida Idaho Louisiana Missouri Mississippi North Carolina New Hampshire New Mexico Nevada New York Ohio Oklahoma Pennsylvania South Dakota Washington

Questions about this recall

Why was it 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.

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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