# FDA recall Z-0410-2026

> **Medistim Asa** · Class II · device recall initiated 2025-09-26.

## 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

- **Recall number:** Z-0410-2026
- **Recalling firm:** Medistim Asa
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-26
- **Report date:** 2025-11-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oslo, N/A, Norway

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0410-2026. Retrieved 2026-08-18 from https://api.ai-analytics.org/recall/Z-0410-2026. Source: US FDA. Licensed CC0.

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