Recall Z-0410-2026 ยท DPW Flowmeter, Blood, Cardiovascular
Medistim Asa
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
| Date | Oct 29, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 | 14 |
| Distribution | Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102595 | MEDISTIM VERIQC SYSTEM Medi-Stim Asa, Dec 27, 2010 |