Events

Rappel de Device Recall Maxi Move Patient Lift with Scale

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 Arjo, 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
    37064
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0796-2007
  • Date de mise en oeuvre de l'événement
    2007-01-05
  • Date de publication de l'événement
    2007-05-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-09-02
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49840
  • 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
    Patient Lift - Product Code FSG
  • Cause
    The hanger bar assembly may detach from the maxi move lifters with scale, due to an incorrect torque setting on the two bolts holding the scale in place.
  • Action
    Arjo sent Urgent Device Field Correction Recall Notice letters dated 1/5/07 to the end user accounts who received the affected lifts, advising them of the potential for the hanger bar assembly to detach. They were informed that an Arjo Field Service Technician would call them within five business days to schedule the time for him to visit and perform the inspection and correction to the lifts involved. If they did not hear from the technician within that time, they were instructed to contact the Arjo Quality Department at 800-323-1245, ext. 6140. The accounts were also requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter.

Device

Device Recall Maxi Move Patient Lift with Scale
  • Modèle / numéro de série
    Model number KMMB4ELU2FUS, serial numbers SEE0624509, SEE0624510, SEE0624511, SEE0624512, SEE0624513, SEE0624514, SEE0624515   (Manufactured week 24 of 2006 through week 28 of 2006. You can check the model and serial number of your unit by looking at the serial number label on the mast of the lift, located underneath the removable battery. Serial numbers are all structured SEEYYWWXXX, where ¿ YY = the last two digits of the year,  ¿ WW = the two digits of the production week, and ¿ XXX = the sequential number the unit was in production that week ¿ Example: SEE06024001 = the first unit produced in week 24 of 2006.   If your equipment has one of the model numbers listed above and a serial number beginning with SEE0624 through SEE0628, it is affected by this notification, regardless of the last three digits of the serial number.)
  • Distribution
    Nationwide
  • Description du dispositif
    Maxi Move Patient Lift with Scale; Manufactured by Arjo Hospital Equipment AB, Eslov, Sweden; Model KMBB4ELU2FUS
  • Manufacturer
    Arjo, Inc.

Manufacturer

Arjo, Inc.
  • Adresse du fabricant
    Arjo, Inc., 50 Gary Ave Ste A, Roselle IL 60172-1684
  • Source
    USFDA