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.
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.
Recall #: Z-0319-2026; Quantity: 45 units
Recall #: Z-0320-2026; Quantity: 17 units
Recall #: Z-0321-2026; Quantity: 50 units
Recall #: Z-0322-2026; Quantity: 14 units
Recall #: Z-0323-2026; Quantity: 19 units
Recall #: Z-0324-2026; Quantity: 3 units
Recall #: Z-0325-2026; Quantity: 3 units
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.
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.