Z-0410-2026Class II

Medistim Asa

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Medistim Asa

Product type

Device

Status

Ongoing

Report date

2025-11-05

Distribution

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

Firm state

N/A

Product quantity

Initiated by

Voluntary: Firm initiated

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

Code / lot 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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →