medical MODERATE Updated 2025-02-19

Elekta, Inc. recalls MOSAIQ Oncology Information System

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Recalled Product

MOSAIQ Oncology Information System

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Hazard / Issue

Image offsets calculated by oncology Information System software may be incorrect for Linear Accelerator (LINACs) not characterized at IEC61217 scale.

Issued by

FDA

Affected States: PA, AL, FL, IA, UT
Lot/Code Info: Software versions /UDI: 3.1.2.0 (01)07340201500026 3.1.3.0 (01)07340201500026; 3.1.3.1 (01)07340201500026; 3.1.3.2 (01)07340201500026; 3.1.3.3 (01)07340201500026; 3.1.3.4 (01)07340201500026; 3.2.1.0 (01)07340201500071; 3.2.1.1 (01)07340201500071; 3.2.1.2 (01)07340201500071; 3.2.1.3 (01)07340201500071; 3.2.1.4 (01)07340201500071

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for MOSAIQ Oncology Information System →

If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.

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