FDA recall Z-0410-2026

Medistim Asa · Class II · device

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-09-26
Report date: 2025-11-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Oslo, N/A, Norway

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0410-2026