Medistim Asa — Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not applicable Product Descripti
⚠️ 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.
Is this relevant to me?
- Geography
- CO, MI, MN, TN, TX
- Source agency
- FDA
- Category
- Health
- Published
- September 26, 2025
Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
What's affected?
- 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
- Brand
- Medistim Asa
- Lot code
- Serial
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14.
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