Medistim Asa: Device Recall
Recall #Z-0410-2026 · 09/26/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0410-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Medistim Asa
- Status
- Ongoing
- Date Initiated
- 09/26/2025
- Location
- Oslo, N/A, Norway
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 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.
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
Distribution Pattern
Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.