🔍 RecallPedia

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

Class I - Dangerous
🏥 Medical Devices Recalled: September 24, 2019 Elekta Impac Software Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    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)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Elekta Impac Software
Reason for Recall:
The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

Product Codes/Lot Numbers:

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)

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1597-2020