Events

Rappel de Device Recall Radiometer, ABL 80, ABL90, ABL 800 FLEX Blood Gas analyzers with AQURE Software version 2.2.0

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 Radiometer America Inc.

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
    75836
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0899-2017
  • Date de mise en oeuvre de l'événement
    2016-11-23
  • Date de publication de l'événement
    2016-12-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-02-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151434
  • 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
    Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
  • Cause
    Design error when displaying additional information in the patient view window; error may result in misreading a parameter and its value.
  • Action
    Radiomet4er sent a letter dated November 30, 2016, to all affected customers via email with a request for customers to complete a return form. Customers/Users were advised to not use the "more" button to expand patient results when viewing them in the AQURE patient view. Customers/Users Radiometer Representative will contact them to schedule a visit of a remote session. During the visit or remote session the representative will run a script on the AQURE system, which serve to remove the misalighnment possibility. It is noted in the letter to customers that expanding the results by using the More button will not affect the stored results. If customers are not the end-user of the affected product ensure that the notification letter is distributed to the final end-user. If any questions regarding the notification letter contact Radiometer America Technical Support at 1-800-736-0600 opt.1. For questions regarding this recall call 440-871-8900.

Device

Device Recall Radiometer, ABL 80, ABL90, ABL 800 FLEX Blood Gas analyzers with AQURE Software v...
  • Modèle / numéro de série
    UDI: (01)05700699335999(10)2.2.0
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US including MI and NY and Internationally to England, Switzerland, and United Arab Emirates.
  • Description du dispositif
    AQURE System || Software Version 2.2.0 || Model #: 933-599 || UDI: (01)05700699335999(10)2.2.0 || Catalog number: 933-599 || The AQURE system manages Radiometer blood gas and immunoassay analyzers and results from 3rd party devices for point of care testing placed throughout the hospital. It enables the user to track connected devices, monitor performance and availability, and to quickly resolve and document issues (including allowing the customer to track root cause and corrective action taken). Intended use: The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.
  • Manufacturer
    Radiometer America Inc

Manufacturer

Radiometer America Inc
  • Adresse du fabricant
    Radiometer America Inc, 250 S Kraemer Blvd, Brea CA 92821-6232
  • Société-mère du fabricant (2017)
    Danaher Corporation
  • Source
    USFDA