Events

Rappel de Spacelabs Healthcare qube Compact Patient Monitor, Model 91390

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Spacelabs Healthcare, Llc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    66727
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0351-2014
  • Date de mise en oeuvre de l'événement
    2013-10-17
  • Date de publication de l'événement
    2013-11-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=123184
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
  • Cause
    Spacelabs healthcare qube compact patient monitor, model 91390, may fail to power on due to incorrect programmed microcontroller component.
  • Action
    Spacelabs Healthcare sent the "URGENT -MEDICAL DEVICE CORRECTION Spacelabs Healthcare qube Compact Monitor" letter, dated 01 November 2013, to the US consignees/customers on November 1, 2013. Spacelabs Healthcare will send the customer letter (translated as necessary) to all international subsidiaries and distributors of record via email on November 6, 2013. The letter described the product, problem and actions to be taken. The customers were instructed to advise staff of the potential for the monitor to fail to turn ON. Spacelabs Healthcare will contact their customers at the earliest possible date to schedule a convenient time for Spacelabs to correct all of your facility's affected monitors at no cost. If you have any questions about this corrective action program, please contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support.

Device

Spacelabs Healthcare qube Compact Patient Monitor, Model 91390
  • Modèle / numéro de série
    SERIAL NUMBERS IN THE US:  1390-101940, 1390-101945, 1390-101946, 1390-101947, 1390-101948, 1390-101950, 1390-101951, 1390-101952, 1390-101953, 1390-101954, 1390-101955, 1390-101956, 1390-101957, 1390-101958, 1390-101962, 1390-101963, 1390-101971, 1390-101972, 1390-101973, 1390-101974, 1390-101979, 1390-101980, 1390-101994, 1390-102002, 1390-102003, 1390-102004, 1390-102005, 1390-102006, 1390-102007, 1390-102008, 1390-102009, 1390-102010, 1390-102011, 1390-102012, 1390-102013, 1390-102014, 1390-102015, 1390-102016, 1390-102017, 1390-102018, 1390-102019, and 1390-102020.   SERIAL NUMBER INTERNATIONAL:  1390-101949, 1390-101969, 1390-101970, 1390-101975, 1390-101976,  1390-101977, 1390-101978, 1390-102001, 1390-102021, 1390-102022,  1390-102023, and 1390-102024.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including states of: Georgia, Idaho, New York, Oklahoma, Tennessee, Texas, and Wyoming and in countries of: Bahrain, Canada, France, Great Britain, Poland, and The Netherlands.
  • Description du dispositif
    Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. || The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.
  • Manufacturer
    Spacelabs Healthcare, Llc

Manufacturer

Spacelabs Healthcare, Llc
  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 35301 Se Center St, Snoqualmie WA 98065-9216
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA