🔍 RecallPedia

Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140

Class I - Dangerous
🏥 Medical Devices Recalled: September 3, 2024 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Model UDI-DI: 782115 (01)00884838099043(21); 782101 (01)00884838098275(21); 782140 (01)00884838108646(21) Serial Numbers: 45601 61291 61312 61315 61328 61336 61337 61339 61348 61349 61351 61354 61355 61356 61357 61359 61360 61361 61362 61363 61364 61367 61371 61373 61374 61375 61376 61377 61378 61380 61383 61384 61394 61395 61397 61403 61404 61406 61407 61412 61415 61416 87645 87648 87649 87651 87654 87655
  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 Llc
Reason for Recall:
Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Ingenia 1.5T -For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782115 2) 782101 3) 782140

Product Codes/Lot Numbers:

Model UDI-DI: 782115 (01)00884838099043(21); 782101 (01)00884838098275(21); 782140 (01)00884838108646(21) Serial Numbers: 45601 61291 61312 61315 61328 61336 61337 61339 61348 61349 61351 61354 61355 61356 61357 61359 61360 61361 61362 61363 61364 61367 61371 61373 61374 61375 61376 61377 61378 61380 61383 61384 61394 61395 61397 61403 61404 61406 61407 61412 61415 61416 87645 87648 87649 87651 87654 87655

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3194-2024

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