Endoscopic navigation platform recalled over image layer misalignment in 2D fusion
Surgical Theater is recalling 19 units of its EndoSNAP platform because a software anomaly may misalign secondary image layers against the primary layer.
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 navigation platform can present inaccurate anatomy, and no injuries are reported.
Plain-English summary
The Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, an image processing radiological 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 19 units carrying UDI-DI 00863157000329, 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
- Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software version SNP.1.12.0, imaging processing radiological system
- Manufacturer
- Surgical Theater Inc
- Hazard
- software-anomaly
- image-misalignment
- erroneous-display
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 00863157000329
Distribution
Distributed nationwide across the United States.
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