🔍 RecallPedia

Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Class I - Dangerous
🏥 Medical Devices Recalled: September 14, 2015 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345019, 345021, 345022, 345023, 345024, 345025, 345026, 345027, 345028, 345029, 345031, 345032, 345033, 345034, 345035, 345036, 345037, 345038, 345039, 345040, 345041, 345042, 345043, 345044, 345045, 345046, 345048, 345049, 345051, 345201, 345202, 345203, 345204, 345205, 345206, 345207, 345208, 345209, 345210, 345211, 345212, 345213, 345214, 345215, 345216, 345217, 345219, 345222, 345224 & 345228.
  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 Medical Systems (Cleveland) Inc
Reason for Recall:
The firm discovered Ring/Dot artifact due to X-ray measurement error.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Product Codes/Lot Numbers:

Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345019, 345021, 345022, 345023, 345024, 345025, 345026, 345027, 345028, 345029, 345031, 345032, 345033, 345034, 345035, 345036, 345037, 345038, 345039, 345040, 345041, 345042, 345043, 345044, 345045, 345046, 345048, 345049, 345051, 345201, 345202, 345203, 345204, 345205, 345206, 345207, 345208, 345209, 345210, 345211, 345212, 345213, 345214, 345215, 345216, 345217, 345219, 345222, 345224 & 345228.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0178-2016

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