🔍 RecallPedia

Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

Class I - Dangerous
🏥 Medical Devices Recalled: April 25, 2023 Philips North America Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)00884838103467 (21) Serial Numbers: 530456 530338 530360 530489 530370 530363 530389 530369 530481 530350 530464 530500 530436 530301 530501 530372 530466 530368 530476 530358 530294 530421 530435 530480 530458 530342 530432 530419 530460 530502 530349 530475 530482 530431 530335 530378 530494 530492 530470 530345 530461 530374 530384 530388 530357 530404 530329 530373 530409 530462 530420 530452 530307
  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 North America
Reason for Recall:
Metal mounting box on the rotating scanner on rotor (heat exchanger box) located within the Incisive CT system may become expelled and make contact with other components and cause injury to user or if detached a loud noise will be emitted and the system will shut down
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

Product Codes/Lot Numbers:

UDI-DI: (01)00884838103467 (21) Serial Numbers: 530456 530338 530360 530489 530370 530363 530389 530369 530481 530350 530464 530500 530436 530301 530501 530372 530466 530368 530476 530358 530294 530421 530435 530480 530458 530342 530432 530419 530460 530502 530349 530475 530482 530431 530335 530378 530494 530492 530470 530345 530461 530374 530384 530388 530357 530404 530329 530373 530409 530462 530420 530452 530307

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2260-2023

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