Events

Rappel de Device Recall BCI Advisor Vital Signs 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
    50740
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1326-2009
  • Date de mise en oeuvre de l'événement
    2008-12-22
  • Date de publication de l'événement
    2009-05-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76841
  • 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
    Carbon-Dioxide Gas Analyzer - Product Code CCK
  • Cause
    Recent improvements were made to the advisor case plastic resulting in the inserts being deeply embedded into the plastic. this affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. there have been no adverse events or injuries reported.
  • Action
    An Urgent Product Safety Information, Voluntary Recall Notification, dated 12/22/08, was sent to affected consignees. The notification contained a Safety Action Bulletin which provided actions to be taken. The Safety Action Bulletin described the issue, requested customer to contact Smiths Medical to ensure proper mounting hardware is utilized for those consignees using a roll stand or wall mount. If the consignee further distributed the product, they were asked to forward on the Safety Action Bulletin to the end user. Page 3 of the Safety Action Bulletin was asked to be completed and returned to Smiths Medical PM, Inc. A second "Urgent Product safety Information Voluntary Recall Notification" letter dated January 16, 2009 was sent to consignees. The second letter included a risk statement associated with the recalled product.

Device

Device Recall BCI Advisor Vital Signs Monitor
  • Modèle / numéro de série
    serial numbers: AM08070014, AM08070015, AM08080004, AM08080005, AM08080006, AM08080007, AM08080008, AM08080009, AM08080010, AM08080011, AM08080012, AM08080013, AM08080014, AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08080032, AM08080033, AM08080034, AM08080035, AM08080036, AM08080037, AM08080038, AM08080039, AM08080040, AM08080041, AM08080042, AM08080043, AM08080044, AM08080045, AM08080046, AM08080047, AM08080048, AM08080049, AM08080050, AM08080051, AM08080052, AM08080075, AM08080076, AM08080077, AM08080078, AM08080079, AM08090058, AM08090059, AM08090060, AM08090061, AM08090069, AM08090070, AM08090071, AM08090072, AM08090073, AM08090074, AM08090075, AM08090076, AM08090077, AM08090078, AM08090079, AM08090080, AM08090081, AM08090082, AM08090083, AM08090084, AM08090085, AM08090086, AM08090092, AM08090093, AM08090094, AM08090095, AM08090096, AM08090097, AM08100000, AM08100001, AM08100002, AM08100003, AM08100004, AM08100005, AM08100006, AM08100007, AM08100008, AM08100042, AM08100043, AM08100045, AM08100051, AM08100052, AM08100053, AM08100054, AM08100056, AM08100075, AM08100076, AM08100077, AM08100078, AM08100080, AM08100082, AM08100083, AM08100085, AM08100086, AM08100087, AM08100088, AM08100089, AM08100091, AM08100092, AM08100093, AM08100094, AM08100095, AM08100096, AM08100097, AM08100098, AM08100099, AM08100100, AM08100101, AM08100146, AM08110000, AM08110001, AM08110003, AM08110004, AM08110005, AM08110008, AM08110009, AM08110010, AM08110011, AM08110012, AM08110013, AM08110014, AM08110015, AM08110016, AM08110018, AM08110019, AM08110026, AM08110027, AM08110028, AM08110029, AM08110030, AM08110031, AM08110034, AM08110035, AM08110036, AM08110037, AM08110054, AM08110055, AM08110056, and AM08110058.
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Kingdom, and Uruguay.
  • Description du dispositif
    Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. || Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed.
  • Manufacturer
    Smiths Medical PM, Inc.

Manufacturer

Smiths Medical PM, Inc.
  • Adresse du fabricant
    Smiths Medical PM, Inc., N7 W22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA