Events

Recall of Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Llc.

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
    60764
  • Event Risk Class
    Class 2
  • Event Number
    Z-0776-2012
  • Event Initiated Date
    2011-07-13
  • Event Date Posted
    2012-01-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106417
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    One spacelabs medical ultraview sl command module, model 91496, was removed from customer due to software error.
  • Action
    Spacelabs removed one affected unit of Medical Ultraview SL Command Module from a hospital in Troy, MI. during a site visit on July 13, 2011. This recall pertains to one single unit at one location. Contact Spacelabs at 425-657-7200 for questions regarding this recall.

Device

Device Recall Spacelabs Medical Ultraview SL Command Module, Model 91496
  • Model / Serial
    Serial number: 1496-029792
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    One device distributed in Troy, MI.
  • Product Description
    Spacelabs Medical Ultraview SL Command Module, Model 91496. || The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (SpO2) and cardiac output. Acquired data may then be communicated to an information network for display, recording, editing and analysis.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Manufacturer Address
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA