FDA recall Z-0500-2022

Konica Minolta Healthcare Americas, Inc. · Class II · device

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

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

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2021-12-03
Report date: 2022-01-26
Termination date: 2024-01-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2022