FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc.: Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
- Recall number
- Z-1745-2011
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Product
- Siemens Medical Solutions USA, Inc., ACUSON AcuNav ultrasound catheters when using SwiftLink catheter connectors; Model Number: 10348560.
- Status
- Terminated
- Initiated
- 2009-03-20
- Posted
- 2011-03-23
- Terminated
- 2011-04-01
- Reason
- Screen Image Quality. An assembly issue on SwiftLink connectors may cause reduced/degraded image quality when using ACUSON AcuNav ultrasound catheter transducers.
- Root cause
- Process design
- 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.
- Quantity
- 21 units
- Distribution
- Distribution in US and Internationally.
- Lot, serial or model codes
- Serial Numbers: Between 80720001 and 82920068
- 510(k) numbers
- ["K033650","K071234","K992631"]
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 2936884
- Firm city
- Mountain View
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28