Events

Recall of Device Recall V5M TEE Transducer

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
    53691
  • Event Risk Class
    Class 2
  • Event Number
    Z-1392-2011
  • Event Initiated Date
    2009-08-28
  • Event Date Posted
    2011-02-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-03-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86332
  • 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
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • Reason
    If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees centigrade.
  • Action
    Siemens sent a Customer Safety Advisory Notification letter on August 28, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their local Customer Service Engineer would install a software update as soon as it becomes available. Customers were instructed to pass the Customer Safety Advisory Notification letter to all who need to be aware of these issues until the corrective action is completed. For questions regarding this recall call 650-969-9112 or 800-422-8766.

Device

Device Recall V5M TEE Transducer
  • Model / Serial
    Model numbers: -10041461: Acuson S2000;  -8263703: V5Ms Transducer; -10041524: S2000Cardiac Imaging and Quantification;  -10436394: S2000 CV Imaging and Quantification;  -10041525: S2000 Advanced Cardiac Analysis;  -10041501: S2000 Cardiac Application Module;  -10042966: S2000 Cardiac Application Module Upgrade;  -10042990: S2000 Cardiac Application Module- No Physio Upgrade;  -10042991: S2000 Card Application Module with Physio Upgrade;  -100442992: S2000 Card App Module only Upgrade
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and internationally to Canada, China, Czech Republic, Denmark, Germany, Great Britian, Hong Kong, Indonesia, Italy, Japan, Norway, Poland, Portugal, Russian Federation, Singapore, South Korea, Taiwan, and Turkmenistan.
  • Product Description
    V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at software version VA10, VA10A, VA10B, VA10C, VA15, VA15A, VA15B, VA16 or VA16A, manufactured by Siemens Medical Solutions, Mountain View, CA. || Multipurpose mobile software controlled diagnostic ultrasound system and on-screen display for thermal and mechanical indices related to bio-effect mechanisms. Its function is to acquire primary or secondary ultrasound echo data. The V5Ms is a multi frequency, multiplane, phased sector array transducer. It can be introduced into the esophagus to obtain images of the heart structure.
  • 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