Recall Z-0410-2026— Medistim Asa

Name: FDA recall Z-0410-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-26

Class II · Ongoing

Class II FDA medical device recall by Medistim Asa, initiated 2025-09-26. It names one FDA 510(k) clearance: K102595. 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. 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..

Recalling firm: Medistim Asa
Classification: Class II
Status: Ongoing
Initiated: 2025-09-26
Firm location: Oslo, N/A, Norway

510(k) clearances named in this recall

1 on FDA's record

K102595 — MEDISTIM VERIQC SYSTEMMedi-Stim Asa·cleared 2010-12-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.