Events

Recall of Device Recall PowerPark

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Sonosite, 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
    55874
  • Event Risk Class
    Class 2
  • Event Number
    Z-2116-2010
  • Event Initiated Date
    2010-05-27
  • Event Date Posted
    2010-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92115
  • 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
    Ultrasonic Pulsed Doppler Imaging System - Product Code IYN
  • Reason
    Powerpark system has a potential for loss of power at the corresponding wall outlet and/or circuit due to poor alignment.
  • Action
    On 05/27/10, SonoSite began contacting their consignees by telephone. On 06/01/10, SonoSite sent out the URGENT-MEDICAL DEVICE RECALL letter to their consignees. The letter describes the recall product as SonoSite PowerPark. Customers should call the Technical Support at 1-877-657-8118 or e-mail to service@sonosite.com for any questions regarding the recall. The letter instructs consignees to stop using the PowerPark immediately and return the product back to SonoSite in exchange for a full refund. The consignees will be contacted by the firm's Sales Representative and/or Clinical Applications Specialist to schedule an appointment to retrieve the device and deliver a refund.

Device

Device Recall PowerPark
  • Model / Serial
    Serial numbers for the Stand Mounted Assembly (P12822):  03J5RJ; 03J5G2; 03J5RX; 03J5GC; 03J5FN; 03J5RH; 03J5BL; 03J5FF; 03J5D1; 03J5CV; 03J5D0; 03J5GN; 03J4RB; 03J5D4; 03J5G9; 03HPVK; 03J5T3; 03HPVF; 03J4RD; 03J5D3; 03J5G1; 03J5FD; 03J5G5; 03J5CZ; 03J4RC; and 03J4RG.      Serial numbers for the Docking Assembly (P12834):  03J4R0; 03J4R1; 03J5CY; 03J4R4; 03J520; 03J5FK; 03J5G7; 03J5G8; 03J51R; 03J5BF; 03J5BH; 03J4R6; 03J5GJ; 03J5GG; 03J5FL; 3J4RX; 03J5GK; 03J0GR; 03J5RR; 03J5G6; 03J5RC; 03J5FJ; 03J5G5; 03J5RV; 03J5GH; and 03J5RF.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of GA, NM, PA, TX, VA, and WA and country of Australia.
  • Product Description
    PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the V or H Universal stand and the docking assembly is plugged into a wall circuit. It provides a docking and charging station for the V and H Universal Stands. || The product marketing brochure labeled in part: "SonoSite Ltd...21919 30th Drive SE... Bothell, WA 98021, USA".
  • Manufacturer
    Sonosite, Inc.

Manufacturer

Sonosite, Inc.
  • Manufacturer Address
    Sonosite, Inc., 21919 30th Dr Se, Bothell WA 98021-3904
  • Source
    USFDA