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Open, Classified

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

FDA Recall Z-0410-2026 · Posted 2025-10-29

Recalling FirmMedistim Asa
Recall StatusOpen, Classified
Product CodeDPW
Date Initiated2025-09-26
Product Quantity14

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.

Firm Action

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.

Root Cause

Process control

Distribution Pattern

Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102595MEDISTIM VERIQC SYSTEMMedi-Stim Asa · 2010-12-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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