PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 26, 2022 Initiated: December 3, 2021 #Z-0500-2022

Product Description

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

Reason for Recall

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

Details

Units Affected
30 units
Distribution
US Nationwide distribution.
Location
Wayne, NJ

Frequently Asked Questions

What product 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. Recalled by Konica Minolta Healthcare Americas, Inc.. Units affected: 30 units.
Why was this product 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
Which agency issued this recall?
This recall was issued by the FDA Devices on January 26, 2022. Severity: Moderate. Recall number: Z-0500-2022.