Events

Recall of Device Recall Quantix/Or Ultrasound Probe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neoprobe Corp.

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
    30795
  • Event Risk Class
    Class 2
  • Event Number
    Z-0701-05
  • Event Initiated Date
    2004-12-13
  • Event Date Posted
    2005-04-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36613
  • 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
    Flowmeter, Blood, Cardiovascular - Product Code DPW
  • Reason
    The probe's faceplate seal can fail and allow penetration of cleaning fluids during the cleaning and soaking cycle between uses or ingress of biohazard fluids during surgical procedures.
  • Action
    The recalling firm notified cutomers by telepone and e mail beginning on 12/2/04.

Device

Device Recall Quantix/Or Ultrasound Probe
  • Model / Serial
    All serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Domestic accounts: Boston University Medical Center, 88 E. Newton St., B-402, Boston, MA 02118; Criticor, 2943 Pullman St., Santa Ana, CA 92705; Ilex Medical, 370 Cypress Creek Circle, Olsmar, FL 34677; Peerless Medical Corp., 705 Summer Oak Dr., Ellisville, MO 63021; Rolomac International, 1836 NE 213 Ln., Miami FL, 33179; University of Miami, PO Box 01690 (R-114), Miami, FL 33101. Foreign accounts: Asia Health Care Co Ltc., 4 FL-3, No 601, Chung Cheng Rd., Taipei, Taiwan, R.O.C.; Century Medical Inc., 1-6-4 Osaki, Shinagawa-KU, Tokyo, Japan 141-8588; Farmplex Cardic, Sheldare Enterprises, Ltd., 20-22 Bedford Row, London, United Kingdom; Integmed Ltd., 51 Hung To Road Kwun Tong, Kowloon, Hong Kong; Reysas Medical Corp., Hulya Sokal No. 21 GOP, 06700 Ankara, Turkey; Rahn AG, Dorflistrasse 12, CH-8050, Zurici, Switzerland.
  • Product Description
    Product is CSN00200 4MHz blood flowmeter probe used with the Quantix/OR system.
  • Manufacturer
    Neoprobe Corp

Manufacturer

Neoprobe Corp
  • Manufacturer Address
    Neoprobe Corp, 425 Metro Pl N Ste 300, Dublin OH 43017-1367
  • Source
    USFDA