The Recall Desk
HighFDA (Devices)·Z-0410-2026·Announced 2025-11-05

[pending] Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC040

Pending LLM rewrite. Source: FDA_DEVICE Z-0410-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

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
Manufacturer
Medistim Asa

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (16)

  • 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

Distribution

Distributed in 5 states:

  • CO
  • MI
  • MN
  • TN
  • TX