Events

Recall of ESPRIT VENTILATOR, Model V1000

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics California 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
    26432
  • Event Risk Class
    Class 1
  • Event Number
    Z-0951-03
  • Event Initiated Date
    2001-06-08
  • Event Date Posted
    2003-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27672
  • 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
    unknown device name - Product Code CPK
  • Reason
    Material hardness on original design check valve may cause premature failure.
  • Action
    Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001.

Device

ESPRIT VENTILATOR, Model V1000
  • Model / Serial
    All Codes.
  • Distribution
    Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada, Brazil, Argentina.
  • Product Description
    ESPRIT VENTILATOR, Model V1000
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92009
  • Source
    USFDA