Events

Rappel de Device Recall Karma

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 Karman Healthcare 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
    73159
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1025-2016
  • Date de mise en oeuvre de l'événement
    2016-01-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143292
  • 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
    Wheelchair, mechanical - Product Code IOR
  • Cause
    Karman healthcare, inc. is recalling karma flexx wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
  • Action
    On 01/27/16 the firm sent out customer notification letters. In the letter customers were informed that the firm was conducting a product update for original purchasers of KM8522. Customers were provided the following procedures for the product update: 1. Completed and signed notification must be returned to Karman Healthcare via fax at (626)-581-2335, or e-mail to edward@karmanhealthcare.com. 2. Following the received frame, customers may install their current wheels, and footrest onto the newly updated frame. Kindly package the used frame into the carton in the same manner the new carton was shipped. 3. A prepaid return shipping label is included with the letter, which customers may use to return the carton; or contact the firm's customer service line at (800)-805-2762 to have a trained representative schedule a pickup at no charge.

Device

Device Recall Karma
  • Modèle / numéro de série
    Item #  935-0245H6 Flexx (KM852216) Serial #  TM14-A03982-TM14-A03991  Item # 935-0246H6 Flexx (KM852218) Serial #  TM14-A03992-TM14-A04012  Item # 935-0247H6 Flexx (KM852220) Serial #  TM14-A4013-TM14-A04017
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    U.S. distribution to the following states -- WA, CA, NY, and TX.
  • Description du dispositif
    Karma Flexx Wheelchair || Manual Wheelchair.
  • Manufacturer
    Karman Healthcare Inc

Manufacturer

Karman Healthcare Inc
  • Adresse du fabricant
    Karman Healthcare Inc, 19255 San Jose Ave, City of Industry CA 91748-1418
  • Société-mère du fabricant (2017)
    Karman Healthcare Inc
  • Source
    USFDA