Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97707

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 26, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medistim Asa

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0410-2026
Recall number
Z-0410-2026
Initiated
September 26, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medistim Asa
Quantity
14

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 pattern

Domestic distribution to CO, MI, MN, TN, TX. International distribution to Australia, Austria, Germany, Finland, India, Japan, Russia, China, Saudi Arabia.