CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report

Mosaiq Oncology Information System recalled by Elekta

Elekta is recalling Mosaiq Oncology Information System, distributed nationwide in the US. The recall was initiated on 24 Nov 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesVersions prior to 2.60.

Quantity recalled211

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-0447-2016
FDA event ID: 72725
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Terminated
Recall initiated: 24 Nov 2015
FDA classified: 17 Dec 2015
Reported: 23 Dec 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Medical Software

Timeline

24 Nov 2015	Recall initiated by company
17 Dec 2015	Classified by FDA	+23 days
23 Dec 2015	Published in enforcement report	+6 days

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

Reason for recall

First Databank (FDB) is a third party product incorporated into MOSAIQ. FDB routinely modifies drugs in their database to reflect market and formulary changes. In FDB Framework v2.0, those drugs are not being included in drug-drug, drug-allergy and duplicate drug therapy interaction checking.

Product as listed by the FDA

MOSAIQ Oncology Information System. Used to manage workflows for treatment planning and delivery.

Where it was distributed

Nationwide Distribution -- AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WY, & Puerto Rico.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland

Questions about this recall

Why was it recalled?

Which lots are affected?

Versions prior to 2.60.

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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