Events

Alerte De Sécurité sur Precise RX Pediatric Flowmeter

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Invacare Corporation.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2016-07-25
  • Date de publication de l'événement
    2016-07-25
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160725b.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: invacare precise rx pediatric flowmeter health canada posted a medical device safety alert concerning invacare precise rx pediatric flowmeter [model numbers: ircpf16, ircpf16aw; lot numbers: 16bf017557, 16cf030112, 16cf030121, 16cf032024, 16cf040071, 16cf040083, 16df040094], manufactured by invacare corporation. the manufacturer has identified that the rear gradation scale was screen printed upside down on the flowmeter gauge. proper delivery of oxygen is critical to infants. in the population at greatest risk i.E. pediatric population, health impact specific to high oxygen saturation could result in systemic toxicity, potential lung vascular injury, or over extended period of time could cause blindness. for details, please refer to the following health canada website: http://healthycanadians.Gc.Ca/recall-alert-rappel-avis/hc-sc/2016/59460r-eng.Php if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 25 july 2016.

Device

Precise RX Pediatric Flowmeter
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Invacare Precise RX Pediatric Flowmeter
  • Manufacturer
    Invacare Corporation

Manufacturer

Invacare Corporation