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Terminated

Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.

FDA Recall Z-1745-2011 · Posted 2011-03-23

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2009-03-20
Date Terminated2011-04-01
Product Quantity21 units

Reason for Recall

Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.

Firm Action

Siemens Field correction was initiated on 3/20/2009. A device correction letter was distributed to all affected users, with a description of the problem and its corrective actions. Siemens service personnel will make a site visit.

Root Cause

Process design

Distribution Pattern

Distribution in US and Internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071234ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10FSiemens Medical Solutions USA, Inc. · 2007-06-29K033650ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETERSiemens Medical Solutions USA, Inc. · 2004-02-24K992631ACUNAV DIAGNOSTIC ULTRASOUND CATHETERAcuson Corp. · 1999-12-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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