ImagePilot recallZ-0500-2022 · Konica Minolta Healthcare Americas, Inc. · initiated Dec 3, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Konica Minolta Healthcare Americas, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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
FDA root cause category: Under Investigation by firm
What the company is doing
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 representative. Konica Minolta Healthcare or Business Partner will contact each site to schedule a visit. A Konica Minolta Representative will be contacting you within 30 days to schedule a visit. The dispatched representative will perform a check and repair process and alert the customer if any repair was needed to any of the images on the lmagePilot server. If image repair is needed, we recommend the images that were previously sent to PACS, NAS or burned to media be exported again. Questions contact your Konica Minolta representative or the Konica Minolta 24-hour Technical Support Department at 1-800-945-0456.
Recall details
- Recall number
- Z-0500-2022
- Status
- Terminated
- Initiated by the company
- Dec 3, 2021
- Recalling firm
- Konica Minolta Healthcare Americas, Inc.
- Quantity
- 30 units
- Product code
- LLZ
- FDA submissions
- K210066
- Distribution
- US Nationwide distribution.
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
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- ImagePilot V1.92R00EKonica Minolta, Inc. · System, Image Processing, Radiological1 recall0 reports
- ImagePilot V1.93R00EKonica Minolta, Inc. · System, Image Processing, Radiological1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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