Siemens Medical Solutions USA, Inc., ACUSON AcuNav… recallZ-1745-2011 · Siemens Medical Solutions USA, Inc. · initiated Mar 20, 2009
Terminated All recalls posted in March 2011
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.
FDA root cause category: Process design
What the company is doing
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.
Recall details
- Recall number
- Z-1745-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 20, 2009
- Posted by the FDA
- Mar 23, 2011
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 21 units
- Product code
- DQO
- FDA submissions
- K033650, K071234, K992631
- Distribution
- Distribution in US and Internationally.
Product description
Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
Code information (models, lots, serial numbers)
Serial Numbers: Between 80720001 and 82920068
Other devices under the same FDA submission
4 devices cleared under K033650, K071234, K992631 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- AcuNav 8F Ultrasound Catheter 10135936Siemens Medical Solutions USA, Inc. · Catheter, ultrasound, intravascular11 reports
- AcuNav G 8F Ultrasound Catheter 10135910Siemens Medical Solutions USA, Inc. · Catheter, ultrasound, intravascular5 reports
- AcuNav G 10F Ultrasound Catheter 10043342Siemens Medical Solutions USA, Inc. · Catheter, ultrasound, intravascular4 reports
- AcuNav 10F Ultrasound Catheter 08255790Siemens Medical Solutions USA, Inc. · Catheter, ultrasound, intravascular1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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