CLASS II ONGOING Device recall · Reported 1 Apr 2020 · FDA Enforcement Report
Mosaiq, oncology information system recalled by Elekta Impac Software
Elekta Impac Software is recalling Mosaiq, oncology information system. The recall was initiated on 24 Sep 2019 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-1597-2020
- FDA event ID
- 85240
- Recalling firm
- Elekta Impac Software, Sunnyvale, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Sep 2019
- FDA classified
- 26 Mar 2020
- Reported
- 1 Apr 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Medical Software
Timeline
| 24 Sep 2019 | Recall initiated by company | |
| 26 Mar 2020 | Classified by FDA | +184 days |
| 1 Apr 2020 | 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
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Product as listed by the FDA
MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.
Where it was distributed
Worldwide distribution.
Questions about this recall
Is Mosaiq, oncology information system recalled?
Yes. Elekta Impac Software recalled Mosaiq, oncology information system on 24 Sep 2019. The recall is Class II and its status is Ongoing. Recall number Z-1597-2020.
Why was it recalled?
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Which lots are affected?
Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)
Where was it sold?
Worldwide distribution.
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 21 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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