Class II — Konica Minolta Healthcare Americas, Inc.
| Recalling firm | Konica Minolta Healthcare Americas, Inc. |
|---|---|
| Registered facility | Konica Minolta Healthcare Americas, Inc (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| 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 |
| Quantity | 30 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2021-12-03 |
| Classified | 2022-01-14 |
| Terminated | 2024-01-05 |
| Recall number | Z-0500-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Konica Minolta Healthcare Americas, Inc. (Z-0500-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89275/
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