Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011
FDA device recall Z-0410-2026 · posted 2025-10-29 · Open, Classified
Recall details
- Recalling firm
- Medistim Asa
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DPW
- Quantity affected
- 14
- Distribution
- Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
- Date initiated
- 2025-09-26
- Date posted
- 2025-10-29
- Location
- Oslo, Norway
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDISTIM VERIQC SYSTEM (K102595) | Medi-Stim Asa | 2010-12-27 |