Events

Rappel de Device Recall BHM Medical Infrared (IR) Hand Control System

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
    46800
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1233-2008
  • Date de mise en oeuvre de l'événement
    2008-02-20
  • Date de publication de l'événement
    2008-07-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-09-11
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68292
  • 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
    wireless control for patient lift - Product Code FNG
  • Cause
    The ceiling lift may not stop lateral movement after releasing the left (or right) action button on a ceiling lift equipped with an infrared hand control.
  • Action
    Arjo sent Urgent Device Field Correction Notification letters dated 2/15/08 on the BHM Medical letterhead to the end user accounts who received the affected IR remotes, advising them of the potential for the remote to become difficult to operate or to create uncontrolled movement of the ceiling lift. The accounts were instructed to remove the IR remote from service until the field correction is issued by BHM Medical. Instructions for removal of the IR equipment were provided in the Safety Advisory Notice included with the letter. The accounts were requested to complete and return the enclosed customer response form, acknowledging the receipt and understanding of the letter, and indicating the number of units requiring correction.

Device

Device Recall BHM Medical Infrared (IR) Hand Control System
  • Modèle / numéro de série
    There are no serial numbers on the BHM Medical Infrared (IR) Hand Control System, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board. The hand controls were installed on the following ceiling lifts: i) Maxi Sky 600, part LD10111, serial numbers LD-2605-15164, LD30733967, LD30733968, LD480627315, LD-5105-21404;  ii) V4, part 9100021, serial numbers V4-1107-29534, V4-1307-29837, V4-3307-33778, V4-1507-30147, V4-1905-14715, V4-4205-18404, V4-3606-26259, LD-1706-24108, V4-0206-22026, V4-3405-16157, V4-4606-27188, V4-4803-04671, V4-1307-29838, V4-1806-24149, V4-3307-33779, V4-4207-36144; part 9100021.13, serial numbers V4-0805-09557, V4-1006-23261; part 9100023, serial number V4-1406-23773; and part 9101021, serial number V4-0105-08044.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    BHM Medical Infrared (IR) Hand Control System, an optional wireless control component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand control system is composed of two components, part 700.13640.33 - IR hand control, and part 492.00038 - IR receiver board
  • Manufacturer
    Arjo, Inc.

Manufacturer

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