Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU140
Summary
The FDA issued a Class II for Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Ca by Medistim Asa. Reason: Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected device.
Details
Source
Device Recall
External ID
Z-0410-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 14
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.
Distribution
Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-26
Company
Oslo, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medistim Asa) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medistim Asa have FDA actions?
This is the only FDA action we have on record for Medistim Asa in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0410-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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