Events

Rappel de Device Recall HillRom TotalCare Bed

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 Hill-Rom, 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
    54117
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1065-2010
  • Date de mise en oeuvre de l'événement
    2010-01-01
  • Date de publication de l'événement
    2010-03-11
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87520
  • 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
    TotalCare Bed - Product Code FNL
  • Cause
    The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function.
  • Action
    The firm sent a letter to each consignee dated January 4, 2010 advising them that a firm representative will visit the facility to make corrections. Hospitals were requested to take all of the affected beds out of service, if possible, until they are corrected, or to inspect and remove those with a problem out of service until they are corrected if all cannot be removed from service. If you have any questions concerning the recall, please contact Hill-Rom Technical Support at 1-800-445-3720 (U.S.).

Device

Device Recall HillRom TotalCare Bed
  • Modèle / numéro de série
    Serial numbers K285AM5539 through K310AM5864. (Serial numbers K310AM5857 , K296AM5635 , K296AM5629 , K295AM5623 , K306AM5779 , K306AM5777 , K303AM5747 , K303AM5741 , K300AM5677 , K300AM5675 , K299AM5654 , K299AM5651 , K302AM5718 , K301AM5715 , K301AM5712 , K301AM5710 , K301AM5709 , K301AM5707 , K301AM5705 , K301AM5704 , K301AM5702 , K301AM5700 , K301AM5696 , K301AM5695 , K300AM5693 , K300AM5690 , K300AM5686 , K300AM5682 , K299AM5660 , K299AM5653 , K296AM5647 , K296AM5643 , K299AM5656 , K299AM5652 , K302AM5725 , K302AM5723 , K302AM5719 , K301AM5714 , K301AM5698 , K300AM5688 , K299AM5663 , K299AM5658 , K302AM5735 , K302AM5733 , K302AM5731 , K302AM5729 , K302AM5726 , K302AM5724 , K302AM5722 , K302AM5720 , K302AM5716 , K301AM5713 , K301AM5708 , K301AM5706 , K300AM5691 , K294AM5594 , K303AM5761 , K303AM5748 , K303AM5739 , K303AM5760 , K303AM5759 , K303AM5758 , K303AM5757 , K303AM5756 , K303AM5755 , K303AM5754 , K303AM5753 , K303AM5752 , K303AM5751 , K303AM5750 , K303AM5749 , K303AM5738 , K296AM5648 , K296AM5645 , K296AM5642 , K306AM5780 , K306AM5776 , K303AM5740 , K302AM5737 , K302AM5734 , K302AM5732 , K302AM5730 , K302AM5728 , K302AM5721 , K300AM5678 , K300AM5676 , K300AM5674 , K299AM5669 , K299AM5666 , K299AM5665 , K299AM5662 , K296AM5644 , K296AM5641 , K296AM5639 , K296AM5637 , K296AM5631 , K295AM5619 , K308AM5812 , K307AM5797 , K306AM5775 , K306AM5772 , K306AM5771 , K306AM5770 , K306AM5769 , K306AM5768 , K306AM5767 , K306AM5766 , K306AM5765 , K306AM5764 , K306AM5763 , K299AM5671 , K299AM5668 , K299AM5667 , K299AM5664 , K299AM5661 , K299AM5659 , K299AM5655 , K303AM5746 , K303AM5745 , K303AM5744 , K303AM5742 , K294AM5599 , K294AM5584 , K300AM5687 , K300AM5692 , K300AM5689 , K300AM5685 , K300AM5683 , K300AM5673 , K299AM5670 , K302AM5727 , K294AM5595 , K294AM5593 , K294AM5591 , K294AM5590 , K294AM5587 , K299AM5650 , K296AM5649 , K296AM5640 , K296AM5638 , K296AM5636 , K296AM5634 , K296AM5630 , K296AM5628 , K295AM5625 , K295AM5624 , K295AM5622 , K295AM5621 , K295AM5620 , K295AM5618 , K295AM5616 , K295AM5614 , K295AM5612 , K295AM5611 , K295AM5609 , K295AM5607 , K294AM5605 , K294AM5604 , K294AM5600 , K294AM5596 , K294AM5586 , K294AM5585 , K294AM5583 , K294AM5582 , K294AM5579 , K294AM5578 , K299AM5589 , K294AM5601 , K294AM5598 , K294AM5603 , K294AM5592 , K302AM5717 , K301AM5711 , K301AM5699 , K301AM5697 , K300AM5684 , K300AM5672 , K301AM5703 , K301AM5701 , K296AM5646 , K294AM5588 , K294AM5581 , K294AM5580 , K296AM5633 and K295AM5627).
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- United States, Australia, Canada, France, Germany, Mexico, United Arab Emirates and United Kingdom.
  • Description du dispositif
    Hill-Rom TotalCare Bed System, Hill-Rom, Batesville, IN; Model P1900 and P1840. || The product is used as an AC powered adjustable hospital bed.
  • Manufacturer
    Hill-Rom, Inc.

Manufacturer

Hill-Rom, Inc.
  • Adresse du fabricant
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • Société-mère du fabricant (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA