Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radi
Summary
The FDA issued a Class II for Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software ver by Surgical Theater Inc. Reason: A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any s.
Details
Source
Device Recall
External ID
Z-0321-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version SNP.3.12.0, imaging processing radiological system
Lot/Code Info: UDI/DI 00863157000374
Quantity Affected: 50 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-16
Company
Beachwood, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Surgical Theater Inc has 10 FDA actions in our database, including 7 recalls and 3 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Surgical Theater Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Surgical Theater Inc have FDA actions?
Surgical Theater Inc has 10 FDA actions in our database, including 7 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0321-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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