Recall Z-0500-2022 ยท LLZ System, Image Processing, Radiological
Konica Minolta Healthcare Americas, Inc.
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
| Date | Dec 3, 2021 |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Konica Minolta issued Urgent: Medical Device Recall lmagePilot Versions 1.92 and 1.93 Letter to Dealers on 12/8/21 and Customers on 12/15/21 via Fed'X. Letter states reason for recall, health risk and action to take: To ensure the correct sampling pitch is obtained from the AeroDR or Momentum panel, please refer to the enclosed "lmagePilot & AeroDR Start-up Sequence and Notice before Shutting Down lmagePilot." Konica Minolta has issued a countermeasure to minimize the risk of a potential incident. This corrective action can only be carried out on site by a Konica Minolta trained representativ |
| Quantity | 30 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210066 | ImagePilot Konica Minolta, Inc., May 6, 2021 |