Events

Rappel de Device Recall Ultraview SL Command Module

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
    60593
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0690-2012
  • Date de mise en oeuvre de l'événement
    2011-11-03
  • Date de publication de l'événement
    2012-01-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-19
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105892
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Cause
    Nibp pump inside the ultraview sl command module, model 91496, became loose. the pump is suspended by the air hoses and electrical connections, but there can be enough movement to damage internal components and cause the module to fail.
  • Action
    SpaceLabs Healthcare sent a Urgent Field Safety Notice dated November 28, 2011, return receipt requested to all US customers. The letter identified the product the problem and the action needed to be taken by customer. On December 6, 2011, SpaceLabs will send a customer letter (translated as necessary) will be emailed to all international subsidiaries and distributors of record. Records of notification will be maintained to ensure complete notification. Customers were instructed If you hear an unusual rattling noise, tag the module, set it aside and contact your Spacelabs field service engineer. Your field service engineer will be contacting you early in 2012 to schedule a mutually agreeable time to upgrade all of your affected modules. Upgrades will be performed on-site and at no cost to you. For any questions about this corrective action program, please call Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support or, outside the United States, 1-425-657-7200 x5089.

Device

Device Recall Ultraview SL Command Module
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA (nationwide)
  • Description du dispositif
    Ultraview SL Command Module is the Spacelabs Multi-parameter Module. It 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. || 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 (Sp02) 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
  • Adresse du fabricant
    Spacelabs Healthcare, Llc, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Société-mère du fabricant (2017)
    OSI Systems Inc
  • Source
    USFDA