FDA (Devices) recall action 97715
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Surgical Theater is recalling 14 units of its SyncAR SNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 17 units of its Surgical Navigation Advanced Platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 50 units of its PE SNAP imaging platform because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 45 units of its SuRgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling three units of its SpineAR SyncAR SNAP orthopedic augmented reality platform because a software anomaly may misalign secondary image layers.
Surgical Theater is recalling three units of its BrainSTORM Surgical Planner because a software anomaly may misalign secondary image layers against the primary layer.
Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.