Events

Rappel de Device Recall TEMPUS IC PROFESSIONAL

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 Remote Diagnostic Technologies Ltd..

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
    58479
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2183-2011
  • Date de mise en oeuvre de l'événement
    2011-03-25
  • Date de publication de l'événement
    2011-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99439
  • 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
    Physiological Patient Monitor (without arrhythmia detection or alarms) - Product Code MWI
  • Cause
    It was discovered that when a 12 lead ecg is recorded and monitoring is quickly restarted, the ecg can cease functioning.
  • Action
    Remote Diagnostic Technologies, Ltd notified its consignees of the problem and the work-around via letter with the subject line "ECG Issue - Field Action Required" on 03/25/2011. The letter stated that customers can avoid the issues by viewing the recorded ECG for at least 13 seconds. Two diagrams were attached with the letter depicting the conditions under which the issue can occur. Customers can continue to use the device normally in all other respects. The letter states that the firm is working on a software modification which will permanently fix the issue and prevent it from occurring. Customers are to contact the Regulatory Affairs and Operations Manager if they have any questions.

Device

Device Recall TEMPUS IC PROFESSIONAL
  • Modèle / numéro de série
    Identification Numbers: 020001, 020002, 020003, 020004, 020005, 020006, 020007, 020008, 020009, 020010, 020011, 020012, 020013, 020014, 020015, 020016, 020017, 020019, and 020020.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- KY, MD, VA, and FL.
  • Description du dispositif
    TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. || Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.
  • Manufacturer
    Remote Diagnostic Technologies Ltd.

Manufacturer

Remote Diagnostic Technologies Ltd.
  • Adresse du fabricant
    Remote Diagnostic Technologies Ltd., The Old Coach House, The Av., Farleigh Wallop, Basingstoke, Hampshire United Kingdom
  • Société-mère du fabricant (2017)
    Remote Diagnostic Technologies Limited
  • Source
    USFDA