Events

Rappel de Device Recall DatexOhmeda

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 Datex-Ohmeda 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
    26765
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0937-03
  • Date de mise en oeuvre de l'événement
    2003-07-15
  • Date de publication de l'événement
    2003-08-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2005-11-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=28387
  • 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
    Gas-Machine, Anesthesia - Product Code BSZ
  • Cause
    Possible disruption of mechanical ventilation or disruption of anesthetic agent delivery.
  • Action
    Recall letters dated July 15, 2003 stated that a firm representative would contact the consignees to schedule a visit to replace CPU boards to correct the problem.

Device

Device Recall DatexOhmeda
  • Modèle / numéro de série
    Serial numbers: 40022312, 40022313, 40027688, 40032184, 40032233, 4002321, 40032330, 40032546, 40036365, 40043483, 40043493 through 40043495, 40043497, 40054495, 40065046, 40065073, 40065818, 40067311, 40067345, 40080026, 40080031, 40080032, 40080035 through 40080037, 40080039, 40080041, 40080042, 40080056, 40080063, 40080064, 40080070, 40080073, 40082935, 40082937 through 40082941, 40082975, 40082979, 40082980, 40082981, 40082986 through 40082989, 40083005, 40083008 through 40083028, 40084505, 40084508, 40084509, 40084512, 40084523, 40084524, 40084535 through 40084538, 40085637, 40085638, 40085642 through 40085644, 40085656, 40085666, 40085681, 40085683 through 40085698, 40085700, 40085702 through 40085707, 40085710 through 40085712, 40085723, 40085734 through 40085736, 40086464, 40088538, 40088544 through 40088548, 40088550 through 40088553, 40088574, 40088585, 40088586, 40089324 through 40089328, 40089333 through 40089340, 40089342 through 40089350, 40089359 through 40089363, 40089398, 40089402, 40089420, 40089421, 40092286, 40092287, 40092290, 40092291, 40092368 through 40092372, 40094139, 40094140, 40094142 through 40094149, 40095400 through 40095433, 40097292 through 40097298, 40097314 through 40097319, 40097321, 40098708, 40098711, 40098714, 40098716 through 40098719, 40098725 through 40098738, 40098751 through 40098754, 40100505 through 40100510, 40102542, 40102543, 40103791, 40103792, 40103796, 40103809, 40103810, 40103817, 40103820, 40103821, 40104726, 40104728, 40104733 through 40104747, 40105932, 40105933, 40105944 through 40105946, 40105952 through 40105954, 40106542 through 40106547, 40106549, 40106551, 40106552, 40106568 through 40106585, 40107959, 40107963, 40107964, 40107976 through 40107985, 40107990 through 40107996, 40107998, 40108817, 40108821, 40108832 through 40108846, 40108848 through 40108850, 40108853, 40109523 through 40109525, 40109531, 40109532, 40109534 through 40109544, 40109546, 40109550, 40110654 through 40110673, 40110684 through 40110688, 40110700, 40110702, 40110703, 40111775 through 40111783, 40111791 through 40111795, 40111804, 40111807 through 40111809, 40112657, 40112659 through 40112661, 40113737, 40113747 through 40113749, 40113755, 40113761, 40113762, 40113767, 40113768, 40113770 through 40113774, 40114922 through 40114928, 40114931 through 40114933, 40115990 through 40116023, 40117237 through 40117244, 40118114 through 40118116, 40118125, 40119844, 40119864, 40119867 through 40119873, 40120169 through 40120178, 40120182, 40120183, 40120908 through 40120917, 40120920, 40120924, 40120929, 40120930, 40120932, 40122181, 40122187, 40122189, 40122627, and 40132124
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed nationwide to hospitals in the Unites States.
  • Description du dispositif
    Datex-Ohmeda S/5 Anesthesia Delivery Units
  • Manufacturer
    Datex-Ohmeda Inc

Manufacturer

Datex-Ohmeda Inc
  • Adresse du fabricant
    Datex-Ohmeda Inc, One Ohmeda Dr. Box 7550, Madison WI 53707
  • Source
    USFDA