ACUNAV SWIFTLINK CABLE
Received Jun 11, 2026 · Event occurred Jun 3, 2026
Report 3023245-2026-00042 · MDR key 25474876
Device
Generic name
Catheter, Ultrasound, Intravascular
Manufacturer
Siemens Medical Solutions Usa, Inc.Model number
08255715Product problems
- Poor Quality Image
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS ONGOING AT SIEMENS HEALTHINEERS TO IDENTIFY THE ROOT CAUSE OF THE ISSUE. THE REPORT WILL BE SUPPLEMENTED AFTER THE INVESTIGATION IS COMPLETED. REFERENCE# (B)(4).
Description of Event or Problem
THE SWIFT-LINK ADAPTER USED ON THE SC2000 SYSTEM REPORTEDLY HAS POOR IMAGE QUALITY AFTER JUST HAVING IT REPLACED AND IT IS NOT ALWAYS RECOGNIZING THE CATHETER. THIS OCCURRED DURING AN EXAM RESULTING IN A 20-MINUTE DELAY. THE PATIENT WAS UNDER GENERAL ANESTHESIA, AND THE EXAM WAS COMPLETED WITH ALTERNATE IMAGING. THERE WAS NO PATIENT IMPACT REPORTED.