Events

Recall of Passport V Monitor

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mindray DS USA, Inc., dba Datascope Patient Monitoring.

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
    55572
  • Event Risk Class
    Class 2
  • Event Number
    Z-1785-2010
  • Event Initiated Date
    2010-04-28
  • Event Date Posted
    2010-06-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-06-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91153
  • 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
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    An issue with the passport v monitor has been identified where the arrhythmia analysis, st analysis and invasive blood pressure functions are not operational.
  • Action
    Mindray issued Corrective action letters directly to all customers beginning April 28, 2010 by certified mail, return receipt requested. consignees were informed of the affected product. For further information, contact Mindray DS USA, Inc. at 1-201-995-8391.

Device

Passport V Monitor
  • Model / Serial
    Part Number 6100F: Domestic Serial Numbers: PV 02018-K9, PV02024-K9, PV02039-K9, PV01999-K9, PV02004-K9, PV02017-K9, PV02020-K9, PV01687-I9, PV01694-I9, PV01702-I9, PV02325-K9, PV02043-K9, PV01403-I9, PV01509-I9, PV01675-I9, PV02229-K9, PV02011-K9, PV02045-K9, PV02044-K9, PV02037-K9, PV02300-K9, PV01412-I9, PV01411-I9 and PV01695-I9; and  Foreign Serial Numbers: PV01470-I9, PV01924-J9, PV0926-J9, PV01989-K9, PV01994-K9, PV01997-K9, PV02330-K9, PV02332-K9, PV02744-A0, PV03005-A0, PV03006-A0, PV03007-A0, PV01965-K9, PV01970-K9, PV01971-K9, PV02056-K9 and PV02057-K9.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (OH, TX, AZ, NY, MO, IL, FL and TN), Spain, Indonesia, Brazil, Italy, Columbia and British West Indies.
  • Product Description
    Passport V Monitor: Mindray, North America. Mindray DS USA, Inc. Mahwah, NJ 07430. || Intended for intra hospital use under the direct supervision of a healthcare practitioner for the monitoring of various human physiological parameters.
  • Manufacturer
    Mindray DS USA, Inc., dba Datascope Patient Monitoring

Manufacturer

Mindray DS USA, Inc., dba Datascope Patient Monitoring