Events

Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield) Zero-Gravity ceiling mounted monorail with hinged swing arm, Zero-Gravity floor unit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Biotronik Australia Pty Ltd 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
    RC-2016-RN-01289-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01289-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The zero-gravity radiation protection system achieves its nearly weightless support of the body shield by employing a steel cable attached to a balancer. two reports from users of the system suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise) without allowing the cable to unwind to its normal condition may cause the cable to break suddenly and the body shield to fall. while no injuries or deaths occurred in either failure, the zero-gravity body shield weighs 25 kg, and in the event of a cable failure, the body shield will fall immediately. a fall of this nature places the user, associated staff and the patient at risk for a potentially serious injury.
  • 조치
    Biotronik will be contacting users and arranging for the replacement of the cable. In addition, the instructions for use and protocols will be updated to include a step to allow the cable to unwind after each use. In the interim, users should inspect the cable for signs of wear or rotational tension that may have created a bend or buckle in the cable. Also, users should review their routine use of the Zero-Gravity Radiation Protection System to determine if the body shield undergoes repeated rotation without allowing the cable to relax back to its normal condition. If the cable has been consistently rotated in one direction without being allowed to relax back to its normal condition or if there is any doubt about excessive rotation in one direction, it is recommended that use is discontinued until the cable is replaced. If facilities continue to use the System until the cable is replaced, they should make sure that they are allowing the unit to go back to its relaxed state. This action has been closed-out on 25/05/2017.

Device

Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield) Zero-Gr...
  • 모델명 / 제조번호(시리얼번호)
    Zero-Gravity Radiation Protection System (overhead suspended radiation protection shield)Zero-Gravity ceiling mounted monorail with hinged swing armCatalogue Number: 412766TIDI Part Number: ZGCM-HSASerial Number: 582023Zero-Gravity floor unitCatalogue Number: 403803TIDI Part Number: ZGM-6.5HSerial Number: 549772Supplied and installed between 28 June 2010 and 31 August 2016ARTG Number: 221225
  • Manufacturer
    Biotronik Australia Pty Ltd

Manufacturer

Biotronik Australia Pty Ltd
  • 제조사 모회사 (2017)
    Ms Holding Ii Se
  • 제조사 의견
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    DHTGA