Augmented reality spine platform recalled over image layer misalignment in fusion
Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: misaligned image layers on a surgical augmented reality platform can present inaccurate anatomy, and no injuries are reported.
Plain-English summary
The SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, an orthopedic augmented reality system from Surgical Theater, is being recalled.
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 layers against the primary image layer.
The recall covers 3 units carrying UDI-DI 00860003884126, distributed worldwide including in Michigan, Florida, the District of Columbia, Minnesota, California, Texas, New Jersey, Pennsylvania, Arizona, New York, Kentucky, Indiana and West Virginia. The FDA has classified the action as Class II.
The enforcement record describes the software anomaly and reports no injuries. Sites running the affected version should follow the firm's instructions.
The recalled product
- Product
- SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
- Manufacturer
- Surgical Theater Inc
- Hazard
- software-anomaly
- image-misalignment
- erroneous-display
- augmented-reality
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI/DI 00860003884126
Distribution
Distributed nationwide across the United States.
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