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CLASS II · ModerateFDA

Medistim Asa recalls Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System

📅 Sep 26, 2025 · 📍 CO, MI, MN, TN, TX
Recalling company
Medistim Asa
Product
Brand 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
Reason
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Sep 26, 2025
Reported
Nov 5, 2025
Distribution
Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
Status
Ongoing
Quantity
14
Lot / codes
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
Company location
Oslo, N/A
Recall type
Voluntary: Firm initiated
Recall number
Z-0410-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0410-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.