CombiDiagnost R90 R.1.0

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    REF number 709030 Serial number 10001076
  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:
Philips has identified a compliance issue where ProxiDiagnost N90 R.1.0, CombiDiagnost R90 R.1.0 and CombiDiagnost R90 R1.1 systems are missing a certification label required by the Food and Drug Administration (FDA).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

CombiDiagnost R90 R.1.0

Product Codes/Lot Numbers:

REF number 709030 Serial number 10001076

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1588-2023

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The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

Apr 14, 2026 Other Medical Devices Nationwide View Details →