Events

Recall of Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs.

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-0176-06
  • 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=42350
  • 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

Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs.
  • Model / Serial
    All Spectrum Monitors that have the following Software Versions: A.19, A.20, B.23, B.24, B.25, B.27, C.18, D.07, E.07, F.09, F.16, F.17, F.26.
  • 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
    Spectrum Patient Monitor, Physiological, Patient with arrhythmia detection or alamrs. Monitor can monitor, display, trend and print a patient''s physiological parameters. The device has a 12.1 inch color display and has a standard configuration of a 3 or 5 lead ECG, Masimo SET SpO2, non-invasive blood pressure, respiration, continuous temperature and IV Drug Calculations. Optional digital displays are provided for invasive blood pressure (up to four) anesthetic agents, O2 and NO2, ST, and CO2.
  • Manufacturer
    Datascope Corp

Manufacturer

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