Recall Z-0500-2022— Konica Minolta Healthcare Americas, Inc.
Class II · Terminated
Class II FDA medical device recall by Konica Minolta Healthcare Americas, Inc., initiated 2021-12-03, terminated 2024-01-05. It names one FDA 510(k) clearance: K210066. 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: 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.
- Recalling firm
- Konica Minolta Healthcare Americas, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-12-03
- Terminated
- 2024-01-05
- Firm location
- Wayne, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.