Events

Rappel de Device Recall Welch Allyn ProBP 2400 Digital Blood Pressure Device

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 Welch Allyn 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
    76552
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1777-2017
  • Date de mise en oeuvre de l'événement
    2017-02-27
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153506
  • 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
    System, measurement, blood-pressure, non-invasive - Product Code DXN
  • Cause
    A defective electrical component in the battery charging circuit in two lots of the probp 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. this potential defect resides with the device, not the battery. the over-voltage condition can result in high nimh battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components.
  • Action
    Welch Allyn sent an Urgent Medical Device Recall letter and Response Forms dated February 21, 2017. They were mailed to the first round of customers beginning on Monday February 27, 2017, via US Postal Service Priority Mail. Welch Allyn will follow up with second round of mailings to the additionally identified end users the week of March 20, 2017. All end users will be instructed to confirm that their unit is affected; and if affected, a replacement unit will be provided so that the affected unit can be returned and scrapped. --- Of the 1120 units, a total of 981 units were distributed from Welch Allyn warehouses and 139 units remained under Welch Allyn control and were not distributed. These units have since been destroyed. For further questions, please call (844) 360-8220.

Device

Device Recall Welch Allyn ProBP 2400 Digital Blood Pressure Device
  • Modèle / numéro de série
    Lot Number 0715: Serial Number range (21)07150001 -  (21)07150620; Lot Number 1215: Serial Number range (21)12150001 -  (21)12150500; --- Note: (21) is NOT part of the serial number. It is the Global Unique Device Identification (GUDI) Application Identifier that precedes the serial number on any GUDI compliant label.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) Distribution
  • Description du dispositif
    Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
  • Manufacturer
    Welch Allyn Inc

Manufacturer

Welch Allyn Inc
  • Adresse du fabricant
    Welch Allyn Inc, 4341 State Street Rd, Skaneateles Falls NY 13153-5300
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA