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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