Events

Recall of NanoMaxx ultrasound system

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
    56428
  • Event Risk Class
    Class 3
  • Event Number
    Z-0478-2011
  • Event Initiated Date
    2010-08-13
  • Event Date Posted
    2010-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93649
  • 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, imaging, pulsed doppler, ultrasonic - Product Code IYN
  • Reason
    Software arm version 60.80.101.025 (referred to as nano1.0.5) on the nanomaxx ultrasound system results in errors when the "print" command is selected. as a result, the displayed mi or ti values may be incorrect.
  • Action
    Sonosite issued Urgent Medical Device Correction letters dated August 9, 2010 to consignees. Consignees were advised of the software problem and given directions to verify the software version they are using. They are advised to contact SonoSite at 877-657-8118 to obtain a free software upgrade.

Device

NanoMaxx ultrasound system
  • Model / Serial
    Part code: P11111-35. Serial numbers: 03HQF4, 03HQF3, 03HQF6, 03HQCM, 03HPZK, 03HQ9X, 03H9C3, 03HKN6,   03HPQ9, 03H87H, 03HQ9M, 03HQ9Q, 03HQB2, 03HQB3, 03HQBB, 03HQBX,   03HQBY, 03HQBZ, 03HQC2, 03HQC3, 03HQC4, 03HQC5, 03HQC6, 03HQCC,   03HQCD, 03HQCF, 03HQCG, 03HQCH, 03HQCJ, 03HQCK, 03HQCN, 03HQCP,   03HQCX, 03HQD2, 03HQD3, 03HQD4, 03HQD5, 03HQD8, 03HQD9, 03HQDB,   03HQDD, 03HQDF, 03HQDG, 03HQDH, 03HQDK, 03HQDL, 03HQDN,   03HQDP, 03HQFL, 03HQ77, 03H16Q, 03HKM7, 03HQBH, 03HQD6, 03HQCL,   03HQ6M, 03HQFG, 03HQF5, 03HQB9, 03HQDC, 03HQDT, 03HQDX, 03HQF0,   03HQF2, 03HQF7, 03HPL9, 03HQD7, 03HQC0, and 03HQFJ.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA and to the countries of Australia, Great Britain, India, Israel, the Netherlands, New Zealand, Norway, and Spain.
  • Product Description
    The software is ARM version 60.80.101.025 (referred to as Nano 1.0.5). || The software is used with the SonoSite NanoMaxx ultrasound system.
  • Manufacturer
    Sonosite, Inc.

Manufacturer

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