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.
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510(K) Database | 510(K)s with Product Code = LLZ
|