Class II U.S. Food and Drug Administration

Surgical Planner, BrainSTORM, software version BST.9.3.0 recall: A software anomaly, under specific conditions when large rotational alignment

Recall published 12 months ago

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 hazard: Device malfunction

A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

What the notice says: 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.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0325-2026
Published
November 5, 2025
Risk level
Class II
Status
Terminated
Issued by
U.S. Food and Drug Administration
Brand
Surgical Theater Inc
Product type
Medical devices
Units affected
3 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI/DI 00860003884119
UPC codes
00860003884119

Products covered by this recall

Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00860003884119

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Surgical Theater Inc — A malfunction was identified in this device. What matters most is whether your particular unit falls inside the affected model, lot or serial range.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. If you are a clinic or facility, quarantine affected stock and record the correction in your recall log.
  3. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  4. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Surgical Theater Inc — 23645 Mercantile Rd Ste M, Beachwood, OH, 44122-5936

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Surgical Theater Inc medical devices 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 layer(s) to the primary image layer. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00860003884119. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Where was the recalled product sold?

It was distributed nationwide.

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