Reported Jan 26, 2022 · Terminated

ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on…

Konica Minolta Healthcare Americas, Inc.

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

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Konica Minolta Healthcare Americas, Inc. · 411 Newark Pompton Tpke · Wayne, NJ · 07470-6657

Is this the product you have?

  • ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on display monitors
  • for medical diagnostics Product numberADFR and ADJC
Lot codes and dates
  • Software Versions 1.92 and 1.93
  • Serial Numbers
    • 996TDF3
    • F6H9BZ2
    • 1MRNVD3
    • 1MMCVD3
    • 8WD00C3
    • GQT78B3
    • GQT68B3
    • 1KMHK93
    • GSFH2G3
    • 2UA5112C16
    • 2UA5122N7T
    • 1MMDVD3
    • 5YZ0N83
    • 1KNCK93
    • DHPJ8B3
    • GRF9673
    • 8WDWZB3
    • 1KMCK93
    • 1KN6K93
    • 1KNGK93
    • 1KNDK93
    • GQP58B3
    • DHQN8B3
    • 1KN8K93
    • 1MSNVD3
    • G3M7773
    • 9VQZ1G3
    • 9VP02G3
    • 5QQWR33
    • 1KMFK93
  • UDI NumberV1.92: 04560141949492 V1.93: 04560141949584
Amount recalled
30 units

Where it was sold

  • Nationwide

Why it was recalled

lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length measurement/area calculation if incorrect power sequence is followed

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

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 5, 2024 · Data as of Sep 19, 7:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.