ImagePilot Versions 1 — Class II medical device recall Z-0500-2022
Terminated recall by Konica Minolta Healthcare Americas, Inc., reported 2022-01-26, distributed nationwide. lmagePilot versions 1.92 and 1.93 paired with an AeroDR or Momentum Panel potential risk of incorrect length m
| Recall number | Z-0500-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Konica Minolta Healthcare Americas, Inc., Wayne, NJ, United States |
| Recall initiated | 2021-12-03 |
| Classified | 2022-01-14 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2024-01-05 |
| Distributed | Nationwide (US) |
| Quantity | 30 units |
| UPC / GTIN / UDI-DI | 04560141949492, 04560141949584 |
| Serial numbers | 1KMCK93, 1KMFK93, 1KMHK93, 1KN6K93, 1KN8K93, 1KNCK93, 1KNDK93, 1KNGK93, 1MMCVD3, 1MMDVD3, 1MRNVD3, 1MSNVD3, 2UA5112C16, 2UA5122N7T, 5QQWR33, 5YZ0N83, 8WD00C3, 8WDWZB3, 996TDF3, 9VP02G3, 9VQZ1G3, DHPJ8B3, DHQN8B3, F6H9BZ2, G3M7773 and 5 more |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0500-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.