FDAFDA · Food and drugs·Recall number Z-0319-2026
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Published November 5, 2025 · Recall initiated: September 16, 2025
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Surgical Theater Inc
- Distributor
- Worldwide - US Nationwide distribution in the states of MI, FL, DC, MN, CA, TX, NJ, PA, AZ, NY, KY, IN, WV and the countries of Italy, Germany, Israel, UK.
- Lot
- UDI/DI 00863157000336
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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