CLASS II Device recall · Reported 26 Jan 2022 · FDA Enforcement Report
ImagePilot Versions recalled by Konica Minolta Healthcare
Konica Minolta Healthcare Americas is recalling ImagePilot Versions 1.92 and 1.93, distributed nationwide in the US. The recall was initiated on 3 Dec 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0500-2022
- FDA event ID
- 89275
- Recalling firm
- Konica Minolta Healthcare Americas, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2021
- FDA classified
- 14 Jan 2022
- Reported
- 26 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 3 Dec 2021 | Recall initiated by company | |
| 14 Jan 2022 | Classified by FDA | +42 days |
| 26 Jan 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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
Which lots are affected?
Software Versions 1.92 and 1.93 Serial Numbers: 996TDF3 F6H9BZ2 1MRNVD3 1MMCVD3 8WD00C3 GQT78B3 GQT68B3 1KMHK93 GSFH2G3 2UA5112C16 2UA5122N7T 1MMDVD3 5YZ0N83 1KNCK93 DHPJ8B3 GRF9673 8WDWZB3 1KMCK93 1KN6K93 1KNGK93 1KNDK93 GQP58B3 DHQN8B3 1KN8K93 1MSNVD3 G3M7773 9VQZ1G3 9VP02G3 5QQWR33 1KMFK93 UDI Number: V1.92: 04560141949492 V1.93: 04560141949584
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | nGenuity Patient Monitor with Capnography recalled | Criticare Technologies | Device Malfunction | Nationwide |
| Device | CLASS I | Bravo CF capsule delivery device, Product Number FGS recalled | Given Imaging | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |