Events

Recall of Device Recall ACUSON AcuNav ultrasound catheters

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    52904
  • Event Risk Class
    Class 2
  • Event Number
    Z-1745-2011
  • Event Initiated Date
    2009-03-20
  • Event Date Posted
    2011-03-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84253
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    ultrasound catheter - Product Code DQO
  • Reason
    Screen image quality. an assembly issue on swiftlink connectors may cause reduced/degraded image quality when using acuson acunav ultrasound catheter transducers.
  • 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.

Device

Device Recall ACUSON AcuNav ultrasound catheters
  • Model / Serial
    Serial Numbers: Between 80720001 and 82920068
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebird Way, P.O. Box 7393, Mountain View CA 94043
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA