Events

Device Recall HillRom TotalCare Bed 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Hill-Rom, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    54117
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1065-2010
  • 사례 시작날짜
    2010-01-01
  • 사례 출판 날짜
    2010-03-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87520
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    TotalCare Bed - Product Code FNL
  • 원인
    The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function.
  • 조치
    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
  • 모델명 / 제조번호(시리얼번호)
    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).
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Australia, Canada, France, Germany, Mexico, United Arab Emirates and United Kingdom.
  • 제품 설명
    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.
  • 제조사 주소
    Hill-Rom, Inc., 125 E Pearl St, 1069 State Route 46 East, Batesville IN 47006
  • 제조사 모회사 (2017)
    Hill-Rom Holdings, Inc
  • Source
    USFDA