The Recall Desk
HighFDA (Devices)·Z-0319-2026·Announced 2025-11-05

Surgical planning software recalled over image layer misalignment in 2D fusion

Surgical Theater is recalling 45 units of its SuRgical Planner 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 planning platform can present inaccurate anatomy, and no injuries are reported.

Plain-English summary

The SuRgical Planner (SRP), software version SRP.7.12.0, 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 45 units carrying UDI-DI 00863157000336, 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
SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological system
Manufacturer
Surgical Theater Inc
Category
Medical Device — Imaging software
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 00863157000336

Distribution

Distributed nationwide across the United States.

Related recalls

Same category