Z-0410-2026Class II

Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001...

Name: Z-0410-2026 Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001...
Creator: Medistim Asa
Published: 2025-09-26
License: https://open.fda.gov/license/

Medistim ASA / initiated 2025-09-26 / Open, Classified / root cause: manufacturing process

FDA source

Medistim Asa began a recall of Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011 Software Version: Not... on 2025-09-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0410-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-26
Posted: 2025-10-29
Recalling firm: Medistim ASA
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
Product code: DPW Flowmeter, Blood, Cardiovascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 14
Distribution: Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0410-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0410-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-29

Product code DPW

K102595Class IIMedistim Veriqc SystemMedi-Stim Asa / cleared 2010-12-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)