Focalyx Fusion

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• Focalyx Fusion

Lot codes and dates

• UDI-DI00860003552001
• 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

Amount recalled

18

Where it was sold

• Nationwide
• NY
• MA
• FL

Why it was recalled

Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.

This product could cause temporary or reversible health problems — stop using it.