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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Medistim MiraQ Ultrasound Systems Recalled for Unexpected Shutdown Risk

Agency Publication Date: October 29, 2025
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Summary

Medistim Asa is recalling 14 Medistim MiraQ Systems, which are ultrasound devices used during surgery. The Printer Support Module (PSM) in these units may have insufficient soldering, which can cause internal wires to loosen and lead to an unexpected system shutdown. This recall affects model numbers MQC04001, MQC14001, MQU14011, and MQV12011.

Risk

The device may shut down unexpectedly during a surgical procedure due to loose internal wiring. This failure could result in delays in treatment or an interruption in critical patient monitoring during surgery.

What You Should Do

  1. This recall affects the Medistim MiraQ System, an ultrasound device used during surgery, specifically models MQC04001, MQC14001, MQU14011, and MQV12011.
  2. Check the model and serial number located on your device label to determine if your unit is one of the 14 affected systems. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact Medistim Asa or your local distributor to arrange for the replacement of the Printer Support Module.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medistim MiraQ System (Ultrasound device for intraoperative use)
Model / REF:
MQC04001
MQC14001
MQU14011
MQV12011
Serial Numbers:
5042
5043
5044
5061
5062
5064
5065
5066
5067
5037
5073
5038
5045
5063

Quantity affected: 14 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97707
Status: Active
Manufacturer: Medistim Asa
Sold By: Professional medical distributors
Manufactured In: Norway
Units Affected: 14
Distributed To: Colorado, Michigan, Minnesota, Tennessee, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.