🔍 RecallPedia

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

Class I - Dangerous
🏥 Medical Devices Recalled: August 27, 2021 PTW NORTH AMERICA Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust
  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:
PTW NORTH AMERICA CORPORATION
Reason for Recall:
When a measurement with a PTW detector array is performed with the software BeamAdjust 2.2 or VeriSoft 8.0, a measurement error can occur under specific conditions. This error can lead to a too-low or too-high measured absolute dose which affects patient plan verification results
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032

Product Codes/Lot Numbers:

S/N :AU2001094-1 UDI: EPTWS0700090 VeriSoft ;EPTWS0700090 BeamAdjust

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0479-2022