Medistim Asa recalls Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog N…
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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: NoModel number
What the firm is doing
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.
DistributionShow detailsHide
Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0410-2026
- FDA 510(k) clearance · K102595The device's official FDA premarket clearance record
- FDA device classification · DPWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.2100The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medistim AsaSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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