Konica Minolta Healthcare Americas, Inc
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
- Inspections (1)
Devices registered here (2)
- System, X-Ray, StationaryProduct code KPR (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680
- Solid State X-Ray Imager (Flat Panel/Digital Imager)Product code MQB (opens in a new tab) · Class II · Radiology · 21 CFR 892.1680
Recalls & enforcement
- Class IITerminated2021-12-03lmagePilot 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 IITerminated2018-11-08Unintentional U-Arm movement
FDA inspections (1)
- VAI2017-08-25Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices; Radiation Control and Health Safety Act · citations posted
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Konica Minolta Healthcare Americas, Inc (FEI 3002885429) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3002885429-konica-minolta-healthcare-americas-inc/
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