Events

Rappel de Device Recall Actiwatch 64 AM,

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 Mini-Mitter Company, 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
    38368
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0326-2008
  • Date de mise en oeuvre de l'événement
    2007-06-27
  • Date de publication de l'événement
    2008-01-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65464
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Notes supplémentaires dans les données
    Patient Physiological Monitor - Product Code M HX
  • Cause
    Communication failure: the devices have a memory chip that has a limited number of read/write cycles which can trigger set up information and/or subject information anomalies or intermittent communication annomalies. if left unaddressed, the issues can lead to permanent communication failure.
  • Action
    A Voluntary Medical Device Recall letter dated June 26, 2007. The recall letter will instruct the customers to 1) fill out a business reply form to confirm contact information and devices serial numbers in their possession. Then FAX this info back immediately to Stericycle or Mini-Mitter. 2) Refer to the work scheduled rework date reserved for them and noted in their recall notification letter and return the device for service at that time; and 3) Package the device appropriately, insure it and return it via UPS using the provided UPS shipping label. Product returned to Mini-Mitter will be quarantined, decontaminated, and repaired. Min-Mitter will rework all the devices returned. Each will have a new memory chip installed, be re-calibrated, retested, and have a new battery installed if required. Min-Mitter will provide a new one year warranty.

Device

Device Recall Actiwatch 64 AM,
  • Modèle / numéro de série
    Serial Numbers: V960132, V960133, V960135, V960191, V960253, V960254, V960255, V960256, V960257, V960314, V960460, V960461, V960469, V960481, V960483, V960487, V960488, V960504, V960505, and V960550
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide
  • Description du dispositif
    Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Respironics, Inc., Mini Mitter, a Respironics Company, Bend, Oregon
  • Manufacturer
    Mini-Mitter Company, Inc.

Manufacturer

Mini-Mitter Company, Inc.
  • Adresse du fabricant
    Mini-Mitter Company, Inc., 20300 Empire Ave Ste B3, Bend OR 97701
  • Société-mère du fabricant (2017)
    Mini Mitter Co Inc
  • Source
    USFDA