HIGHFDA DEVICE

MOSAIQ Oncology Information System

Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

ElektaHealth & Personal CareMedical DevicesSoftware Version: MOSAIQ 3.2/UDI: 07340201500071

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
May 21, 2026
Status
ACTIVE

Quick Facts at a Glance

Recall Date
May 21, 2026
Hazard Level
HIGH
Brand
Elekta
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Elekta
Model numbers
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    May 21, 2026

  2. Reported by FDA DEVICE

    June 17, 2026

  3. RecallRadar source check

    June 23, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Elekta, Inc. or your healthcare provider for instructions. Notification method: Letter

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Full Description

MOSAIQ Oncology Information System. Reason: Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.. Classification: Class II. Quantity: 12 programs. Distribution: 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.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Brand
Model Numbers
Software Version: MOSAIQ 3.2/UDI: 07340201500071
Affected States
ALL
Report Date
June 17, 2026
Recall Status
ACTIVE

Related Recalls

Health & Personal Care
HIGH

Elekta Recalls MOSAIQ Oncology System Over Overtreatment Risk

Elekta recalled the MOSAIQ Oncology Information System on December 10, 2025. A malfunction may cause overtreatment in patients due to software issues. Healthcare providers should stop using the device immediately and follow recall instructions.

Elekta
Using oncology
Read more