Events

Rappel de Device Recall LifeBand Single Pack (accessory), and Nickelmetal hydride (NIMH) Battery.

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 Zoll Circulation, 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
    68718
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2090-2014
  • Date de mise en oeuvre de l'événement
    2013-07-16
  • Date de publication de l'événement
    2014-07-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-07-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128557
  • 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
    Compressor, cardiac, external - Product Code DRM
  • Cause
    Typographical error in the japanese legal label of the autopulse resuscitation system model 100. the label is specific to the japanese version of the product.
  • Action
    Zoll Japan handled the recall.

Device

Device Recall LifeBand Single Pack (accessory), and Nickelmetal hydride (NIMH) Battery.
  • Modèle / numéro de série
    LifeBand Single Pack: product code 8700-03, lot 41515; Nickel-Metal hyride battery: product code 8700-0702-03: serial numbers: 03690,03695,03696,03700,03701,03702,03706,03707,03708,03709,03710, 03711,03715,03717,03718,03720,03721,03726,03727,03728,03730,03732, 03733,03734,03736,03738,03742,03743,03745,03749,03750,03758,03768, 03770,03772,03773,03778,03779,03781,03782,03783,03786,03788,03797, 03799,03805,03806,03809,03863,03866,03867,03869,03871,03874,03875, 03880,03881,03882,03883,03888,03889,03890,03893,03894,03895,03896, 03899,03901,03906,03910,03916,03926,03943,04064,04067,04100,04119, 04133,04193,04223,04233,04301,04303,04304,04337,04364,04397,04399, 04400,04405,04406,04408,04409,04410,04411,04415,04417,04418,04419, 04420,04421,04422,04423,04433,04442,04468,04470,04478,04482,04483, 04510,04511,04514,04585,04586,04587,04588,04589,04591,04593,04594, 04595,04596,04598,04599,04600,04603,04607,04608,04610,04611,04612, 04617,04619,04635,04641,04662,04674,04675,04676,04678,04679,04682, 04704,04705,04712,04718,04744,04762,04763,04773,04774,04777,04780, 04782,04785,04786,04789,04795,04828,04838.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in Japan.
  • Description du dispositif
    Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. || The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR.
  • Manufacturer
    Zoll Circulation, Inc.

Manufacturer

Zoll Circulation, Inc.
  • Adresse du fabricant
    Zoll Circulation, Inc., 2000 Ringwood Ave, San Jose CA 95131-1728
  • Société-mère du fabricant (2017)
    Asahi Kasei Corp.
  • Source
    USFDA