Recall Z-0410-2026
Medistim Asa · initiated September 26, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
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.
FDA-determined 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.
Details
- Recall number
- Z-0410-2026
- Initiated
- September 26, 2025
- Posted by FDA
- October 29, 2025
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 14
- Distribution
- Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
- Recalling firm
- Medistim Asa, Oslo