Events

Recall of Passport 2 with View 12 ECG Analysis Module.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datascope 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
    33724
  • Event Risk Class
    Class 3
  • Event Number
    Z-0177-06
  • Event Initiated Date
    2005-09-07
  • Event Date Posted
    2005-11-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-06-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42351
  • 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, Cardiac (Incl. Cardiotachometer & Rate Alarm) - Product Code DRT
  • Reason
    Software anomalies which include shut down while printing, invalid diastolic blood pressure display, and incomplete and inaccurate interpretation reports of 12-lead ecg data.
  • Action
    Datascope sent out a Field Correction notice on 9/7/2005 to all Hospital administrators who have the monitors. This was sent out via certified mail, return receipt requested. A Datascope Service Rep will conduct and document the corrective action during a visit to the customer.

Device

Passport 2 with View 12 ECG Analysis Module.
  • Model / Serial
    Passport 2 Monitors with software versions: S.10, T.15, T.31, V.07, W.09, W.13, W.14.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The monitors have been distributed domestically and internationally to hospitals and clinics. There are 10 Passport 2 monitors distributed to Naval Hospital, Camp Pendleton, CA. There are 12 Spectrum monitors distributed to two US Govt facilities: VA Medical Center, Hines, IL and VA Medical Center, Syracuse, NY.
  • Product Description
    Passport 2 with View 12 ECG Analysis Module. It is a transportable, multi-parameter physiological monitor designed to monitor and display the following physiological parameters: ECG, Heart Rate derived from selected sources (Sp)2, ECG, IBP and NIBP), SpO2 level, ST Segment, Arrhythmia, Blood pressure (both invasive and non-invasive), Respiration rate (dirived from ECG or CO2), inspired or expired CO2, temperature , and gases (i.e. five anesthetsia gases, O2, N2O, and CO2)
  • Manufacturer
    Datascope Corp

Manufacturer

Datascope Corp
  • Manufacturer Address
    Datascope Corp, 800 MacArthur Blvd, Mahwah NJ 07430-2001
  • Source
    USFDA