🔍 RecallPedia

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

Class I - Dangerous
🏥 Medical Devices Recalled: June 21, 2016 Philips Medical Systems (Cleveland) Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223
  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:
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ingenuity Core 128, model #728323; Intended to produce cross- sectional images of the body.

Product Codes/Lot Numbers:

901469, 901479, 901487, 901491, 901497, 901502, 901508, 901515, 901517, 901518, 901520, 901530, 901533, 921223

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2114-2016

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Class I - Dangerous

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