Z-0322-2026Class II
SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0...
Surgical Theater Inc / initiated 2025-09-16 / Completed / root cause: software
Surgical Theater Inc began a recall of SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Completed, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-0322-2026
- Classification
- Class II
- Status
- Completed
- Initiated
- Posted
- Recalling firm
- Surgical Theater Inc
- Product
- SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
- Product code
- LLZ System, Image Processing, Radiological
- 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.
- Root cause tag
- software
- FDA root cause
- Under Investigation by firm
- Action
- Surgical Theater issued an URGENT: Medical Device Software correction notice dated September 17, 2025 to its consignees on 09/22/2025 via email. The notice explained the issue, risk to health, and provided the following: Customers can continue to use the software version(s) noted above until a software patch is made available by Surgical Theater. Until the software patch is installed, please follow these steps: 1. Read and share this notice with all relevant staff. 2. Continue to use the 3D Fusion functions to review the fusion results for all case files to verify alignment of secondary layer(s) to primary layer and to adjust fusion as necessary, and 3. Acknowledge your receipt of this notification by completing and returning the included acknowledgement form via email to [email protected]. A software patch is currently undergoing verification and should be available in the next 10 days. Surgical Theater has revised the 2D Image Fusion function to ensure the x, y and z axis rotation values are consistently applied when generating the aligned Axial, Sagittal and Coronal images. In addition, the rotate left/right buttons in all three planes were modified so the volume rotation stays consistent with the respective plane orientation. A Surgical Theater representative will contact your facility to schedule installation once the patch is available. For questions regarding this notification contact: Kevin Murrock, Sr. Director of Quality & Regulatory, Tel. 330-472-6520 (Monday through Friday, 9:00 AM to 5:00 PM, Eastern Time), email: [email protected]
- Quantity in commerce
- 14 units
- 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.
- Product codes and lots
- UDI/DI 00860003884102
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0319-2026 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0320-2026 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0321-2026 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0322-2026 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0323-2026 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0324-2026 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0325-2026 | Class II | Terminated | Voluntary: Firm initiated |
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