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
This recall is currently active, issued October 29, 2025. It was issued by Medistim Asa Okernveien.
- Company
- Medistim Asa Okernveien
- Recall Initiated
- September 26, 2025
- Posted
- October 29, 2025
- Recall Number
- Z-0410-2026
- Quantity
- 14
- Official Source
- View on FDA website ↗
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.
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
Root Cause
Process control
Action Taken
Firm notified impacted consignees by email on September 26, 2025. Consignees were informed that qualified service personnel will perform the correction of the device according to the standard service procedure.