Events

Rappel de Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor

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 Smiths Medical PM, 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
    38472
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1240-2007
  • Date de mise en oeuvre de l'événement
    2007-07-18
  • Date de publication de l'événement
    2007-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53824
  • 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 - Product Code DQA
  • Cause
    Phantom pacer spikes caused by a damaged resistor.
  • Action
    Customers will be notified via a Customer Information Bulletin CIB Tracking Number: 07-CIB 12, July 18,2007 requesting them to evalute the functionality of their monitor (s). If the monitor does not exhibit any false pace detect makers when pace detect is enabled and respiration is disabled, no further action is required. If it does exhibit false pace detect they will be instructed to contact the Smiths Medical PM, Inc service department. At that time Technical Worksheet, 07-TW02, will be provided. The consignee will need to verify they are capable of perfoming the Technical Worksheet provided. The Smiths Medical PM. Inc. Service Manger will veirfy if the consignee is capable of performing the rework.

Device

Device Recall BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor
  • Modèle / numéro de série
    Catalog number/ serial number: 3404001/AI05110052/ AI05120000/ AI05120011/ AI05120012/ AI05120013/ AI05120018/ AI06060015/ AI06070047/ AI06100004/ AI06100005/ AI06100006/ , 3404001S/AI05110000/ AI05110001/ AI05110002/ AI05110003/ AI05110004/ AI05110005/ AI05110006/ AI05110007/ AI05110008/ AI05110009/ AI05110010/ AI05110011/ AI05110012/ AI05110013/ AI05110014/ AI05110015/ AI05110016/ AI05110017/ AI05110018/ AI05110019/ AI05110020/ AI05110021/ AI05110022/ AI05110023/ AI05110024/ AI05110025/ AI05110026/ AI05110027/ AI05110028/ AI05110029/ AI05110030/ AI05110031/ AI05110032/ AI05110033/ AI05110034/ AI05110035/ AI05110036/ AI05110037/ AI05110038/ AI05110039/ AI05120010/ AI05120016/ AI05120017/ AI05120019/ AI06010042/ AI06010043/ AI06060003/ AI06060004/ AI06060005/ AI06060006/ AI06060007/ AI06060008/ AI06060009/ AI06060010/ AI06060011/ , 3404002/AI05090021/ AI05090024/ AI05110049/ AI05120015/ AI06010035/ AI06010036/ AI06010049/ AI06040000/ AI06040001/ AI06040002/ AI06040003/ AI06040004/ AI06040005/ AI06040006/ AI06040007/ AI06040008/ AI06040009/ AI06040010/ AI06040011/ AI06040012/ AI06040013/ AI06040014/ AI06040015/ AI06040016/ AI06040017/ AI06040018/ AI06040020/ AI06060012/ AI06060013/ AI06060014/ AI06060017/ AI06060018/ AI06060019/ AI06060020/ AI06070037/ AI06070038/ AI06070039/ AI06070040/ AI06070042/ AI06070043/ AI06070044/ AI06070045/ AI06090053/ AI06100011/ AI06100012/ AI07010057/ AI07010058/ , 3404002E/AI05110040 AI05110041/ AI05110042/ AI05120001/ AI05120002/ AI05120005/ AI05120006/ AI05120007/ AI05120008/ AI05120009/ AI05120024/ AI06010041/ AI06010044/ AI06010045/ AI06010046/ AI06010048/ AI06040019/ AI06040023/ AI06040024/ AI06070041/ AI06070046/ AI06070048/ AI06070049/ AI06090050/ AI06090051/ , 3404002F/AI07010067/ AI07010068/ , 3404002G/AI05110050/ AI05110051/ AI05120003/ AI05120004/ AI06060021/ AI06060022/ AI06060023/ AI06070035/ AI06070036/ AI06090054/ AI06090055/ AI06090056/ AI06090057/ AI06090058/ AI06100008/ AI06100009/ AI06100010/ AI06100018/ , 3404002S/AI05110043/ AI05110044/ AI05110045/ AI06010037/ AI06010038/ AI06010039/ AI06010040/ AI06060000/ AI06060001/ AI06060002/ AI06060016/ AI06090052/ AI06100019/ AI06100020/ AI06100021/ AI06100022/ AI06100023/ AI06100024/ AI07010050/ AI07010051/
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    World wide: USA including states of KY, MS, PA, LA, and PR and countries of Poland, Mexico, Kuwait, Taiwan, Singapore, Hon Kong, India, Bolivia, Colombia, Chile, Argentia, Brunei Darssalam, Israel, Greece, Romania, Germany, The Netherlands, France, Great Britain, Spain, Brazil, Russia, China.
  • Description du dispositif
    BCI Autocorr Plus Pulse Oximeter/ECG/Respiration Monitor, Catalog Numbers, 3404001 (including S) and 3404002 (including E,F, G, and S) Smiths Medical- a part of Smiths Group plc
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Adresse du fabricant
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA