Events

Recall of Device Recall Spacelabs qube Compact Monitor, Model 91390

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
    71233
  • Event Risk Class
    Class 2
  • Event Number
    Z-1608-2015
  • Event Initiated Date
    2015-05-08
  • Event Date Posted
    2015-05-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136920
  • 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, physiological, patient (with arrhythmia detection or alarms) - Product Code MHX
  • Reason
    The input power can fail even though the power source at the wall has not been interrupted. in addition, there is the potential for the qube compact monitor to fail to turn on. this is a retrospective recall related to a recall initiated in 2012 (z-0403-2013).
  • Action
    The firm sent the Urgent Medical Device Correction- Spacelabs Healthcare Inc.-qube Compact Monitor, Model 91390, Power Input PCBA Failure letter, dated 8 May 2015, via priority service mail to US consignees. This letter described the affected system, problem, actions to be taken by users and corrective actions conducted by Spacelabs. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support

Device

Device Recall Spacelabs qube Compact Monitor, Model 91390
  • Model / Serial
    Serial Numbers:  1390-000054,  1390-000064,  1390-000313,  1390-000047,  1390-000898.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    distributed in North Carolina, Texas, and Wyoming
  • Product Description
    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms.
  • 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