Ingenuity TF PET/CT 882442

Class I - Dangerous

🏥 Medical Devices Recalled: March 28, 2018 Philips Medical Systems (Cleveland) Other Medical Devices

What Should You Do?

Check if you have this product:
UDI: (01)00884838059443(21)2086, Serial Number: 2086; UDI: (01)00884838059443(21)2099, Serial Number: 2099; UDI: (01)00884838059443(21)2095, Serial Number: 2095; UDI: (01)00884838059443(21)2097, Serial Number: 2097
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
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:: A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: terminated

Product Information

Full Description:

Ingenuity TF PET/CT 882442

Product Codes/Lot Numbers:

UDI: (01)00884838059443(21)2086, Serial Number: 2086; UDI: (01)00884838059443(21)2099, Serial Number: 2099; UDI: (01)00884838059443(21)2095, Serial Number: 2095; UDI: (01)00884838059443(21)2097, Serial Number: 2097

Distribution:

Distributed in: US, HI, KS, MO

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2276-2018

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