Events

Recall of Device Recall Prima III TotalSENSE Torso Coil, a Magnetic Imaging Accessory

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by USA Instruments 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
    28693
  • Event Risk Class
    Class 2
  • Event Number
    Z-0849-04
  • Event Initiated Date
    2004-03-19
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32369
  • 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
    System, Nuclear Magnetic Resonance Imaging - Product Code LNH
  • Reason
    A defective capacitor in the body array coil may result in unstable, unreliable performance, with excessive heating of patient's body.
  • Action
    The firm notified the regional Siemens Service Centers by letter on 3/19/2004. The affected coils will be returned to the recalling firm for modification.

Device

Device Recall Prima III TotalSENSE Torso Coil, a Magnetic Imaging Accessory
  • Model / Serial
    USAI P/N: 100352, USAI S/Ns: 310 to 388 (Rev 1 and 2); Siemens P/N: 7578789, Siemens S/Ns: 1010 to 1088.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was shipped to domestic consignees located CT, NY, PA, NC, GA, FL, OH, IN, MN, IL, UT, CA, OR; and foreign consignees in Austria, Denmark, Spain, Hong Kong, China, Netherlands, Japan, Taiwan, Korea, Australia, Turkey, Brazil, Germany.
  • Product Description
    Prima III TotalSENSE Torso Coil (Body Array Coil), labeled as Manufactured by: USA Instruments, Inc. This device is a component of the Magnetom TRIO 3.0T MRI Systems, manufactured by Siemens AG Medical Solutions.
  • Manufacturer
    USA Instruments Inc.

Manufacturer

USA Instruments Inc.
  • Manufacturer Address
    USA Instruments Inc., 1515 Danner Dr, Aurora OH 44202-9273
  • Source
    USFDA