Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System… — Class II medical device recall Z-0410-2026
Ongoing recall by Medistim Asa, reported 2025-11-05, distributed in CO, MI, MN, TN, TX. Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires
| Recall number | Z-0410-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medistim Asa, Oslo, N/A, Norway |
| Recall initiated | 2025-09-26 |
| Classified | 2025-10-29 |
| Reported by FDA | 2025-11-05 |
| Distributed | CO, MI, MN, TN, TX |
| Countries outside the US | AT, AU, CN, DE, FI, IN, JP, RU, SA |
| Quantity | 14 |
| Model numbers | 5042, MQC04001, MQC14001, MQU14011, MQV12011 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0410-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.