Surgical Theater Inc: Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging processing radiological system

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.

Details from the source

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. Distribution: 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. Quantity: 17 units Lot/code info: UDI/DI 00863157000305

UPC codes

00863157000305

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.