CLASS II ONGOING Device recall · Reported 17 Jun 2026 · 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 21 May 2026 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-2406-2026
- FDA event ID
- 98980
- Recalling firm
- Elekta, Atlanta, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 11 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 21 May 2026 | Recall initiated by company | |
| 11 Jun 2026 | Classified by FDA | +21 days |
| 17 Jun 2026 | 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
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MOSAIQ Oncology Information System
Where it was distributed
Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
Nationwide FloridaIowaKansasLouisianaNew JerseyNew MexicoNew YorkTexasWisconsin
Questions about this recall
Why was it recalled?
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Which lots are affected?
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Where was it sold?
Worldwide - US Nationwide distribution in the states of WI, FL, LA, NY, NY, NJ, KS, FL, IA, NM, TX and the countries of Bahrain, Belgium, Canada, China, Denmark, France, Germany, Hong Kong, India, Israel, Italy, Japan, Lithuania, Malta, Mexico, Netherlands, Pakistan, Panama, Poland, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom.
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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