🔍 RecallPedia

Ingenuity Core 128, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Class I - Dangerous
🏥 Medical Devices Recalled: November 10, 2017 Philips Medical Systems (Cleveland) Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286.
  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:
Philips has identified that certain fasteners cannot be confirmed to have been torqued according to specification. If the fasteners were not torqued as specified and a failure occurs while the system is in use, the parts secured by the fasteners may become loose, which may have a potential for harm.
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, (Code 728323) Intended to produce images of the head and body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Product Codes/Lot Numbers:

Code 728323, SN # 320394, UDI: (01)00884838059474(21)320394; 320395, UDI: (01)00884838059474(21)320395; and 336286.

Distribution:

Distributed in: US

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0391-2018

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Class I - Dangerous

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