SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 00863157000336
  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:
Surgical Theater Inc
Reason for Recall:
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system

Product Codes/Lot Numbers:

UDI/DI 00863157000336

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0319-2026

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