🔍 RecallPedia

Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

Class I - Dangerous
🏥 Medical Devices Recalled: October 9, 2023 Philips North America Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: (01)00884838059450 Serial Numbers: Serial Number 7362 75114 7441 7449 7996 7104 7333 7991 7497 7762 7254 7373 7674 7783 7971 7802 7385 7840 7353 750010 75107 8007 7990 7716 7689 7618 75045 7442 750017
  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:
For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Brilliance CT Big Bore Oncology with software version V4.8.0.10421 Model:728243 CT scanner and simulator designed for radiation oncology and therapy.

Product Codes/Lot Numbers:

UDI-DI: (01)00884838059450 Serial Numbers: Serial Number 7362 75114 7441 7449 7996 7104 7333 7991 7497 7762 7254 7373 7674 7783 7971 7802 7385 7840 7353 750010 75107 8007 7990 7716 7689 7618 75045 7442 750017

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0294-2024

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