Events

Recall of Device Recall Optimus

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Philips Ultrasound, 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
    33411
  • Event Risk Class
    Class 2
  • Event Number
    Z-1084-05
  • Event Initiated Date
    2005-02-24
  • Event Date Posted
    2005-11-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-09-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41820
  • 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, X-Ray, Stationary - Product Code KPR
  • Reason
    Systems do not comply with the labeling performance standards.
  • Action
    On/about 2/24/04 the firm''s representatives began visiting sites to apply appropriate labeling. The firrm''s representatives will test units to verify compliance.

Device

Device Recall Optimus
  • Model / Serial
    serial #s - G15733, G15704, G15729, G14262, G15750, G15500, G15726, G14065, G15516, G15622, G14118, G14504, G15525, G15551, G14444, G14445, G14406, G15810, G15855, G16651, G16167, G15861, G15858, G15921, G15974, G16132, G16567, G16678, G17593, G16259, G16146, G16573, G17052, G17556, G17504, G16347, G17520, G17506, G17400, G17773, G17774, G17403, G16393. One unit identified with site #103950.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Devices were distributed to 38 medical centers and hospitals throughout the US.
  • Product Description
    Optimus 30
  • Manufacturer
    Philips Ultrasound, Inc.

Manufacturer

Philips Ultrasound, Inc.
  • Manufacturer Address
    Philips Ultrasound, Inc., 22100 Bothell-Everett Hwy., P.O. Box 3003, Bothell WA 98041-3003
  • Source
    USFDA