Events

Recall of Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare 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
    78989
  • Event Risk Class
    Class 2
  • Event Number
    Z-0532-2018
  • Event Initiated Date
    2018-01-17
  • Event Date Posted
    2018-01-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161031
  • 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
    System,network and communication,physiological monitors - Product Code MSX
  • Reason
    Spacelabs has received multiple complaints reporting telemetry beds dropping off the spacelabs central station resulting in a loss of monitoring.
  • Action
    On January , 2018, a customer letter was sent via priority service, return receipt requested, to all U.S. customers. International consignees will be notified on January 24 , 2018, by email. The letter stated: " Please weigh the benefits versus the risks when deciding whether or not to continue to use your Exhibit Telemetry Receiver(s) until updated as set forth below. We recommend that you brief your staff regarding the failure mode listed above." Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to update your Exhibit Telemetry Receiver(s) to software version 1.0.2 at no cost." For further questions, please call (800) 522-7025.

Device

Device Recall Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1
  • Model / Serial
    Serial numbers: 6280-000359, 6280-000340, 6280-000336, 6280-000503, 6280-000502, 6280-000500, 6280-000496, 6280-000495, 6280-000327, 6280-000260, 6280-000566, 6280-000290
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : VA, NJ, MI, GA, and Internationally to France
  • Product Description
    Spacelabs Healthcare Xhibit Telemetry Receiver, Model 96280, software version 1.1, physiological patient monitor (with arrhythmia detection or alarms) || The Spacelabs Healthcare Telemetry Receiver, Model 96280, is intended to provide the Spacelabs Healthcare monitoring system with adult, pediatric and neonatal patient data of patients connected to Spacelabs Healthcare telemetry transmitters. Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Manufacturer Address
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA