Events

Rappel de Device Recall Bakers Pride Model E300 Speed Ovens

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 Standex Intl Corp.

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
    77581
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2614-2017
  • Date de mise en oeuvre de l'événement
    2017-01-01
  • 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=156620
  • 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
    Microwave oven, consumer - Product Code RCR
  • Cause
    It was discovered that all five microwave ovens fail to have concealed or inaccessible safety interlocks.
  • Action
    The Standex Cooking Solutions Group plans to replace all 149 Bakers Pride Model E300 Speed Ovens remaining in the field as follows : 1.Product design changes include (a) an updated interlock switch mounting that reduces the effects of shipping and handling on switch positioning; (b) a revised mechanism for the secondary interlock switch to prevent operation by any part of the human body or any object with a straight insertable length of 3.9 inches. A 200,000-cycle leakage measurement is conducted and will be finished by July 31, 2017. 2.The updated replacement oven will be shipped with the improved, stronger bracing materials and added cover over the handle with markings and changes in the door mechanism. 3.New compliant ovens will be delivered by an installer to distributors and owners. 4.All shipping and installation costs for delivery of the new units and return of the old units will be paid by Standex International Corporation. 5.The updated and corrected pages of the Service Manual and Owners Manual will be included with the delivery of the replacement oven, and the corrected warning label and Certification label will be permanently affixed to the replacement ovens. 6.Standex International Corporation expects to deliver the replacement units after testing, which will be completed by July 31, 2017. Distributors and customers will then be given a period of 4 weeks to return the old unit. 7.All returned ovens will be updated to revised construction and subjected to the full Unit Test Procedure required for new products. Ovens that cannot be updated will be destroyed. 8.Progress reports will be provided to FDA on the 15th of every month until all non-compliant ovens have been replaced with new compliant ovens, returned to the factory and modified to the revised and compliant construction, as verified by conducting the Unit Test Procedure. CDRH approves the CAP subject to the following conditions: 1.Notification of all dealers and

Device

Device Recall Bakers Pride Model E300 Speed Ovens
  • Modèle / numéro de série
    S/N: 562071609002 562071706001 562071608015 562071609003 562071608014 562071609001
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution
  • Description du dispositif
    Standex International Bakers Pride Microwave Ovens Model E300
  • Manufacturer
    Standex Intl Corp

Manufacturer

Standex Intl Corp
  • Adresse du fabricant
    Standex Intl Corp, 11 Keewaydin Dr, Salem NH 03079-2999
  • Source
    USFDA