Events

Recall of Device Recall Finapres Portapres Ambulatory Continuous NonInvasive Blood Pressure Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by FMS, Finapres Medical Systems BV.

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
    62556
  • Event Risk Class
    Class 2
  • Event Number
    Z-2150-2012
  • Event Initiated Date
    2012-07-06
  • Event Date Posted
    2012-08-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110979
  • 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, measurement, blood-pressure, non-invasive - Product Code DXN
  • Reason
    Battery may become hot and leak.
  • Action
    Finapres Medical Systems BV sent a Field Safety Notice letter dated July 6, 2012 to notified US accounts of the recall. The letter identified the affected product, description of the problem and actions to be taken. The letter states that the recalling firm recommends not using the affected battery packs. A replacement battery was included in shipment. Customers were requested to return recalled battery. For questions call +31 (0)20 609 0974 or email info@finapres.com.

Device

Device Recall Finapres Portapres Ambulatory Continuous NonInvasive Blood Pressure Monitor
  • Model / Serial
    Serial Numbers: 12 02 006, 12 02 008, 12 02 013
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution - including the states of: OH and NY
  • Product Description
    Finapres Medical Systems Portapres with NiMh battery pack || Product Usage: || Continuously measure blood pressure, The Portapres can be worn on the body with a protective waist belt. The device can be used without mains; in that case a battery pack is used.
  • Manufacturer
    FMS, Finapres Medical Systems BV

Manufacturer

FMS, Finapres Medical Systems BV
  • Manufacturer Address
    FMS, Finapres Medical Systems BV, Paasheuvelweg 34A, 1105 BJ, Amsterdam Netherlands
  • Manufacturer Parent Company (2017)
    Finapres Medical Systems B.V.
  • Source
    USFDA