Events

Recall of Device Recall Acuson

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
    26006
  • Event Risk Class
    Class 3
  • Event Number
    Z-0865-03
  • Event Initiated Date
    2003-03-31
  • Event Date Posted
    2003-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26858
  • 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
    Monitor, Fetal Doppler Ultrasound - Product Code MAA
  • Reason
    The product has a software condition in that the surface temperature of the transducer may reach above the thermal limit.
  • Action
    On 3/24/03, the firm issued letters via US Mail to all its direct consignees informing them of the affected device and providing instructions on the recall.

Device

Device Recall Acuson
  • Model / Serial
    All Serial Numbers: XXXXXXXX (8-digit)
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide. The product received nationwide distribution to 123 consignees: 23 Distributors (50 transducers) and consumers/users: approximately 100 customers (146 transducers). 2 transducers were consigned to Federal Government locations: (1) Martin Army Community Hospital, 9200 Marne Rd., Fort Benning, GA 31905, (2) Lackland AFB, Wilford Hall, 2200 Bergquist Dr., #100, Lackland AFB, TX 78236. The firm has also distributed product into international channels through distributors. Countries include, Austria; Barbados; Brazil; Canada; China (PRC); Egypt, France, Germany; Greece; India; Italy; Japan; South Korea; Netherlands; Russia; Saudi Arabia; Sweden; Taiwan; and United Kingdom. There is no Canadian distribution. The firm is continuing to obtain the international distribution through the distributors. The recall was appropriately extended to the consumer/user level; i.e., the wholesalers/distributors, and users who received the recalled product.
  • Product Description
    Acuson Diagnostic Ultrasound System Transducer; || Model Number(s): L582 Linear Array Transducer for use on the 128XP Ultrasound System; || Catalog Numbers: 23656 (New), 45441 (Refurb)
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 1230 Shorebire Way, P.O. Box 7393, Mountain View CA 94039-7393
  • Source
    USFDA