# FDA recall Z-0500-2022

> **Konica Minolta Healthcare Americas, Inc.** · Class II · device recall initiated 2021-12-03.

## 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

- **Recall number:** Z-0500-2022
- **Recalling firm:** Konica Minolta Healthcare Americas, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0500-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0500-2022. Source: US FDA. Licensed CC0.

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