The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1243-2026·Announced 2026-02-11

Prostate imaging software recalled over accessories that may fail on Windows 10

Focalyx Technologies is recalling 18 units of Focalyx Fusion because accessories may not function properly with Windows 10, which may cause patient harm during biopsy or delay treatment.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: the firm states the fault may cause patient harm during biopsy or treatment delays, and no injuries are reported.

Plain-English summary

Focalyx Fusion is being recalled by Focalyx Technologies, LLC. The record describes it as a software device that is an accessory for image-guided interventional and diagnostic procedures involving the prostate.

The record states the device has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment or therapy delays, and that the firm is recommending stop use until the device is verified and validated with Windows 11.

The record lists 18 units under UDI-DI 00860003552001, software versions 1.3, 1.5 and 1.6, with serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States in New York, Massachusetts and Florida, and to the countries listed in the record. The FDA has classified the action as Class II.

The enforcement record reports no injuries. Sites should follow the firm's stop use recommendation and its instructions.

The recalled product

Product
Focalyx Fusion
Manufacturer
Focalyx Technologies, LLC.
Category
Medical Device — Image guidance software
Hazard
Affected units
18

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 (20)

  • UDI-DI: 00860003552001. Software Versions: 1.3
  • 1.5
  • 1.6. Serial Numbers: IF-FF-B-1-22080504
  • IF-FF-B-1-TPAA998118
  • IF-FF-B-1-351238
  • IF-FF-B-1-TPAB081335
  • IF-FF-B-1-22080508
  • IF-FF-B-1-TPAB200331
  • IF-FF-B-1-TPAB200333
  • IF-FF-B-1-TPAC505383
  • IF-FF-B-1-TPAB200348
  • IF-FF-B-1-TPAB540364
  • IF-FF-B-1-S5ARQL009253NYZ
  • IF-FF-B-1-SCARQL0014096YZ
  • IF-FF-B-1-TPAB532163
  • IF-FF-B-1-SCARQL00136033KK
  • IF-FF-B-1-TPAB540359
  • IF-FF-B-1-TPAB081326
  • IF-FF-B-1-22080505
  • IF-FF-B-1-TPAB081324

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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