🔍 RecallPedia

Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Class I - Dangerous
🏥 Medical Devices Recalled: February 5, 2016 Philips Medical Systems (Cleveland) Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211.
  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 was notified of a software error in which the system may not automatically send all image/data series to remote devices.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Product Codes/Lot Numbers:

Model No. 728311; S/N: 200011, 200013, 200017, 200022, 200027, 200030, 200032, 200038, 200040, 200047, 200049, 200051, 200061, 200063, 200067, 200068, 200074, 200088, 200093, 200097, 200100, 200101, 200105, 200107, 200109, 200111, 200117, 200121, 200127, 200131, 200138, 200200, 200201, 200202, 200203, 200204, 200205, 200206, 200207, 200208, 200209, 200210 & 200211.

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1353-2016

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Class I - Dangerous

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