26
Jan
2022

Recall – Incorrect area calculation under certain conditions

,
0

Company: Konica Minolta Healthcare Americas, Inc.
Date of Enforcement Report: 1/26/2022
Class II

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

Recall Number: Z-0500-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Konica Minolta Healthcare Americas, Inc. on 12/3/2021. Voluntary: Firm initiated

VOLUME OF PRODUCT IN COMMERCE

30 units

DISTRIBUTION

U.S. Nationwide

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