Medical device recalls Moderate risk

Konica Minolta Healthcare Americas, Inc. recalls ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing and presentation of medical images on displ…

Recall date
December 3, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0500-2022
FDA classification
Class II
Brand / firm
Konica Minolta Healthcare Americas, Inc.
Sold / distributed
US Nationwide distribution.

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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