United StatesSurgical Theater Inc is recalling SuRgical Planner (SRP) version SRP.7.12.0, Surgical Navigation Advanced Platform (SNAP) version SNP.3.12.0, PE SNAP version SNP.3.12.0, SyncAR SNAP version SNP.1.12.0, EndoSNAP version SNP.1.12.0, SpineAR SPR.1.2.0, and Surgical Planner BrainSTORM BST.9.3.0 — imaging processing and orthopedic augmented reality software identified by the listed UDI/DI codes. The products were recalled because a software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may cause misalignment of secondary image layers to the primary image layer.
What's being recalled
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Recalling firm: Surgical Theater Inc, Beachwood, OH, United States.
How to identify it
UDI/DI 00863157000336 UDI/DI 00863157000305 UDI/DI 00863157000374 UDI/DI 00860003884102 UDI/DI 00863157000329 UDI/DI 00860003884126 UDI/DI 00860003884119
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
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)