Events

Rappel de Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator

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 Osypka Medical 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
    56121
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2444-2010
  • Date de mise en oeuvre de l'événement
    2010-06-30
  • Date de publication de l'événement
    2010-09-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93070
  • 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
    pulse-generator, pacemaker, external - Product Code DTE
  • Cause
    The recall was initiated after osypka medical received two (2) complaints from their japanese distributor regarding an incompatibility of the pace 203h with some new types of 9 v batteries. the investigation revealed that pace 203h of a certain manufacturing period malfunction (i.E., not stimulate) when a type of 9 v batteries with higher than usual open circuit voltage (ocv) is used. failure t.
  • Action
    OSYPKA Medical sent "Urgent Medical Device Recall" letters dated June 30, 2010 and July 7, 2010 to the direct customers. The recall notice informed the customers of the Reason for Recall, the Potential Hazard, the Temporary Fix of the Problem, the Permanent Fix of the Problem and Recommended Actions to be taken by the customer. The customers were instructed to contact Osypka Medical via telephone (858) 454-0021 or e-mail to m.osypka@osypkamed.com to verify that the Model 3085 and/or PACE 203H is subject to this product removal, obtain a return-to-manufacturer-authorization (RMA) number ,and then return the affected devices to Osypka Medical. If you have any questions call (858) 454-0021 or e-mail to mail@osypkamed.com

Device

Device Recall St. Jude Medical, Model 3085, DualChamber External Pulse Generator
  • Modèle / numéro de série
    S/N 0311030, 0323107, 0912101 & 0912110 (total = 12)
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: USA including states of CA & FL
  • Description du dispositif
    St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator || The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.
  • Manufacturer
    Osypka Medical Inc

Manufacturer

Osypka Medical Inc
  • Adresse du fabricant
    Osypka Medical Inc, 7855 Ivanhoe Ave Ste 226, La Jolla CA 92037-4561
  • Société-mère du fabricant (2017)
    Osypka Medical Inc
  • Source
    USFDA