CLASS II Device recall · Reported 9 Jun 2021 · FDA Enforcement Report
Mosaic Oncology Information System versions recalled by Elekta
Elekta is recalling Mosaic Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83, distributed nationwide in the US. The recall was initiated on 20 Apr 2021 and the FDA has classified it as Class II.
Check your package
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-1783-2021
- FDA event ID
- 87965
- Recalling firm
- Elekta, Atlanta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Apr 2021
- FDA classified
- 2 Jun 2021
- Reported
- 9 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 20 Apr 2021 | Recall initiated by company | |
| 2 Jun 2021 | Classified by FDA | +43 days |
| 9 Jun 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
Malware attack
Product as listed by the FDA
Elekta MOSAIC Oncology Information System versions: 2.62, 2.64, 2.70, 2.81, 2.82, and 2.83 hosted on Classic Cloud
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Malware attack
Which lots are affected?
v2.62 - no UDI, v2.64 - 00858164002091, v2.70 - 00858164002237, v2.81 - 00858164002282, v2.82 - 00858164002336, v2.83 - 00858164002367
Where was it sold?
Nationwide
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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