🔍 RecallPedia

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Class I - Dangerous
🏥 Medical Devices Recalled: October 9, 2023 Philips North America Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00884838103627; Lot Code: 1005
  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
Reason for Recall:
This recall is part of a 2-issue recall for the same system. When using the IVC needle position button, on the IVC control box during a series of scans, the plan box may not move to the desired needle position. This issue could result in the gantry moving to a location the operator does not expect. If this occurs, it presents a risk that the scan could occur at an incorrect location, or that the unintended motion of the gantry could cause a collision with the user or needle. The other part of the recall involves a software crash when the CCT foot pedal is activated (as described in RES ID93363).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Spectral CT on Rails, Software Version 5.1.0, Model Number 728334

Product Codes/Lot Numbers:

UDI-DI: 00884838103627; Lot Code: 1005

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0319-2024

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