FDA Medical Device Recalls (openFDA)
Surgical Theater Inc: SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SNP.1.12.0, imaging processing radiological system
- Recall number
- Z-0322-2026
- 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
- Status
- Completed
- Initiated
- 2025-09-16
- Posted
- 2025-10-24
- Terminated
- not on file
- Reason
- 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
- 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 quality@surgicaltheater.com. 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: kmurrock@surgicaltheater.com
- Quantity
- 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.
- Lot, serial or model codes
- UDI/DI 00860003884102
- 510(k) numbers
- ["K160584"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 3010197287
- Firm city
- Beachwood
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28