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U.S. Department of Health and Human Services

Class 2 Device Recall Medistim MiraQ System

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 Class 2 Device Recall Medistim MiraQ Systemsee related information
Date Initiated by FirmSeptember 26, 2025
Date PostedOctober 29, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0410-2026
Recall Event ID 97707
510(K)NumberK102595 
Product Classification Flowmeter, blood, cardiovascular - Product Code DPW
ProductBrand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Description: Ultrasound device for intraoperative use Component: No
Code Information Lot Code: Serial number; Model number 5042; MQC04001 5043; MQC04001 5044; MQC14001 5061; MQU14011 5062; MQU14011 5064; MQU14011 5065; MQU14011 5066; MQU14011 5067; MQC04001 5037; MQU14011 5073; MQV12011 5038; MQU14011 5045; MQU14011 5063; MQU14011
FEI Number 3010790133
Recalling Firm/
Manufacturer		 Medistim Asa
Okernveien 94
Oslo Norway
For Additional Information ContactKari Krogstad
+47 23 05 96 60
Manufacturer Reason
for Recall		Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
FDA Determined
Cause 2		Process control
ActionFirm notified impacted consignees by email on September 26, 2025. Consignees were informed that qualified service personnel will perform the correction of the device according to the standard service procedure.
Quantity in Commerce14
DistributionDomestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = DPW
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