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U.S. Department of Health and Human Services

Class 2 Device Recall Konica

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  Class 2 Device Recall Konica see related information
Date Initiated by Firm December 03, 2021
Create Date January 14, 2022
Recall Status1 Terminated 3 on January 05, 2024
Recall Number Z-0500-2022
Recall Event ID 89275
510(K)Number K210066  
Product Classification System, image processing, radiological - Product Code LLZ
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
Code Information 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
Recalling Firm/
Manufacturer		 Konica Minolta Healthcare Americas, Inc.
411 Newark Pompton Tpke
Wayne NJ 07470-6657
For Additional Information Contact Jan Maniscalco
973-633-1500
Manufacturer 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
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 30 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = Konica Minolta, Inc.
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