MiraQ System (Medistim) – printer module failure (2025)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Medistim Asa Okernveien
Lot Codes / Batch Numbers
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
Products Sold
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
Medistim Asa Okernveien is recalling Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001 due to Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CO, MI, MN, TN, TX
Page updated: Jan 10, 2026