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