Events

Recall of Device Recall MicroMaxx LAP Transducer

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
    37452
  • Event Risk Class
    Class 2
  • Event Number
    Z-0661-2007
  • Event Initiated Date
    2007-02-05
  • Event Date Posted
    2007-03-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50572
  • 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
    Laparoscopic Ultrasound Transducer - Product Code IYN
  • Reason
    Laparoscopic transducer exceeds the limits specified for radio-frequency emissions by up to 10db.
  • Action
    On 2/5/2007 firm sent by FED-Ex notification letters to firm representatives. Representatives began hand delivery of recall letter to consignees and retrieval of LAP transducer for return delivery to firm. The letter advised customers that the LAP transducer exceeded the limits specified for radio-frequency emissions. The firm also advised that exceeding the limit may cause the LAP transducer to interfere with surrounding equipment that may be susceptible to radiated emissions and cause surrounding equipment to not perform as expected.

Device

Device Recall MicroMaxx LAP Transducer
  • Model / Serial
    Serial Numbers: 037XT6, 0379P5, 037WMJ, 0379P1, 0379P2, 0379P0 Part Number: P05507-10
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution to USA (Tennessee & Ohio), France, Korea, and Germany.
  • Product Description
    MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer
  • Manufacturer
    Sonosite, Inc.

Manufacturer

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