Events

Recall of Device Recall Ultraview SL Command Module

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
    68357
  • Event Risk Class
    Class 2
  • Event Number
    Z-1705-2014
  • Event Initiated Date
    2014-05-08
  • Event Date Posted
    2014-06-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127459
  • 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
    A software anomaly causes temperature alarm limits to change to limits which are not physiologically possible and result in nuisance false positive alarms.
  • Action
    Spacelabs Healthcare identified a software anomaly in the Ultraview SL" Command Module, Model 91496. During an internal audit, Spacelabs identified a reportable recall that was not reported. We have a product called the Spacelabs Medical Ultraview SL" Command Module, Model 91496. A software error was discovered at a customer site which was not a safety issue, but in the interest of customer service it was decided to downgrade all their modules with an older software version.

Device

Device Recall Ultraview SL Command Module
  • Model / Serial
    All devices of Model: 91496.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to GA.
  • Product Description
    Spacelabs Medical Ultraview SL Command Module, Model 91496. || Arrhythmia Detector and Alarm. The Multi-parameter Module is used with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from a patient in a clinical environment.
  • 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