The Recall Desk
HighFDA (Devices)·Z-0500-2022·Announced 2022-01-26

ImagePilot diagnostic imaging software versions 1.92 and 1.93 measurement error recall

Konica Minolta's ImagePilot versions 1.92 and 1.93 software may provide incorrect measurement calculations if improper power sequences are used with AeroDR or Momentum Panel systems.

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: This FDA Class II recall involves a risk-of-harm product where measurement inaccuracy in diagnostic imaging could impact patient care. No illnesses or injuries have been reported, and the hazard is contingent on improper power sequencing.

Plain-English summary

Konica Minolta Healthcare Americas, Inc. is recalling ImagePilot versions 1.92 and 1.93, medical imaging software designed to process and present medical images on display monitors for diagnostic purposes. When used with AeroDR or Momentum Panel imaging systems, these software versions can produce incorrect length measurements or area calculations if an incorrect power sequence is followed.

The software is used in diagnostic imaging facilities across the United States. Approximately 30 systems containing the affected software versions have been distributed nationwide. The company has identified that improper power sequencing during operation can lead to inaccurate diagnostic measurements.

Healthcare providers and clinicians using these software versions should verify their power sequence procedures match the manufacturer's specifications. Users should contact Konica Minolta Healthcare Americas, Inc. for guidance on identifying if their systems are affected and for information on obtaining corrected software versions.

The recalled product

Product
ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors for medical diagnostics Product number: ADFR and ADJC
Manufacturer
Konica Minolta Healthcare Americas, Inc.
Category
Medical Device — Diagnostic Imaging Software
Hazard
  • measurement-error

Distribution

Distributed nationwide across the United States.

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