🔍 RecallPedia

DigitalDiagnost C50 1.1

Class I - Dangerous
🏥 Medical Devices Recalled: February 25, 2022 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020
  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:
Philips North America Llc
Reason for Recall:
Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of the image on the first examination due to an issue in the firmware of the Wallstand VS2 board. The system will rotate the amplimat field selection by 90 degrees. The wrong amplimat field selection may cause an incorrect dose of radiation to occur. Additionally, the anatomic position markers may become mispositioned and could potentially be associated with the opposite side of the anatomy. (Added 1/3/2023), Expansion of the root cause to include incorrect amplimat field selection by 90 degrees following the first exposure using Wallstand VS2 and a subsequent system restart. Previously, this issue only occurred following a system restart where the Table Height 2 (TH2) is the default setting.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

DigitalDiagnost C50 1.1

Product Codes/Lot Numbers:

Model Number 712204 Serial Number 210182 210187 220002 210049 210051 210097 210052 210053 210055 220020

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1563-2022

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