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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Surgical Theater Imaging Software Recalled for Image Misalignment Risk

Agency Publication Date: October 24, 2025
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Summary

Surgical Theater Inc is recalling approximately 151 units of several surgical planning and navigation software platforms, including the SuRgical Planner (SRP) and SNAP systems. A software anomaly can occur during 2D image fusion, where large rotational adjustments might cause secondary image layers to misalign with the primary image. This defect could lead to inaccurate surgical guidance during medical procedures. Healthcare providers should verify their software version and contact the manufacturer for correction.

Risk

A misalignment in surgical imaging layers could lead to the incorrect placement of surgical instruments or misinterpretation of patient anatomy. This poses a risk of surgical errors that could result in patient injury or complications during neurosurgical or orthopedic procedures.

What You Should Do

  1. This recall affects Surgical Theater software systems including SuRgical Planner (SRP.7.12.0), SNAP and PE SNAP (SNP.3.12.0), SyncAR SNAP and EndoSNAP (SNP.1.12.0), SpineAR SNAP (SPR.1.2.0), and BrainSTORM (BST.9.3.0).
  2. Check your system's software version on the startup screen or about menu to determine if your platform is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled software for clinical procedures if you encounter situations requiring large rotational alignment values during 2D Image Fusion.
  4. Contact Surgical Theater Inc to arrange for a software correction, update, or to receive further instructions on navigating the software anomaly.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: SuRgical Planner (SRP) Imaging Processing Radiological System
Variants: Software version SRP.7.12.0
Model / REF:
SRP.7.12.0
UDI:
00863157000336

Recall #: Z-0319-2026; Quantity: 45 units

Product: Surgical Navigation Advanced Platform (SNAP) Imaging Processing Radiological System
Variants: Software version SNP.3.12.0
Model / REF:
SNP.3.12.0
UDI:
00863157000305

Recall #: Z-0320-2026; Quantity: 17 units

Product: Surgical Navigation Advanced Platform Patient Engagement (PE SNAP) Imaging Processing Radiological System
Variants: Software version SNP.3.12.0
Model / REF:
SNP.3.12.0
UDI:
00863157000374

Recall #: Z-0321-2026; Quantity: 50 units

Product: SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP) Imaging Processing Radiological System
Variants: Software version SNP.1.12.0
Model / REF:
SNP.1.12.0
UDI:
00860003884102

Recall #: Z-0322-2026; Quantity: 14 units

Product: Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP) Imaging Processing Radiological System
Variants: Software version SNP.1.12.0
Model / REF:
SNP.1.12.0
UDI:
00863157000329

Recall #: Z-0323-2026; Quantity: 19 units

Product: SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP) Orthopedic Augmented Reality
Variants: Software version SPR.1.2.0
Model / REF:
SPR.1.2.0
UDI:
00860003884126

Recall #: Z-0324-2026; Quantity: 3 units

Product: Surgical Planner BrainSTORM Orthopedic Augmented Reality
Variants: Software version BST.9.3.0
Model / REF:
BST.9.3.0
UDI:
00860003884119

Recall #: Z-0325-2026; Quantity: 3 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97715
Status: Active
Manufacturer: Surgical Theater Inc
Sold By: Surgical Theater Inc; Direct Sales to Hospitals and Surgical Centers
Manufactured In: United States
Units Affected: 7 products (45 units; 17 units; 50 units; 14 units; 19 units; 3 units; 3 units)
Distributed To: Michigan, Florida, District of Columbia, Minnesota, California, Texas, New Jersey, Pennsylvania, Arizona, New York, Kentucky, Indiana, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.