Alerte De Sécurité sur : PHOTOTHERAPY SYSTEMS: (1) MODEL PTL68, (2) MODEL PTM78, (3) MODEL PTS68; (4) PHOTOTHERAPY SYSTEM LAMPS. PARTS: (1 to 3) UNIDENTIFIED, (4) 1780745

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par HILL-ROM AIR-SHIELDS A HILLENBRAND CO.

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
  • ID de l'événement
    119
  • Date
    2000-09-29
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notes supplémentaires dans les données
    PRODUCT REGISTERED IN BRAZIL ON 06.05.1999 (INSTRUCOM). HOWEVER, UNTIL THIS DATE, STILL HAS NO MARKETING REGISTRATION. INSTRUCOM COMMUNICATES AS SOON AS THE PRODUCT WILL BE EXECUTED, YOU WILL CLARIFY YOUR CUSTOMERS OF THE FACT THAT HAPPENED, A WAY TO GUARANTEE THE QUALITY OF THE PRODUCT. WHEREVER, THEY HAVE ORIGINAL AND PROFESSIONAL REPLACEMENT PARTS QUALIFIED WITH TRAINING BY PROPRIET MANUFACTURER.
  • Cause
    Hill-rom air-shields edited a product service bulletin disclosing that the company received information that hospitals are replacing the phototherapy system lamps by non-authorized lamps, not compatible by the hill-rom . the phototherapy systems mentioned incorporate lamps with a specific reflector. air-shields hill-rom ends that systems operating without this reflector can generate more heat / energy in the light beam, which could cause equipment failures and commit patient and employee safety.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED AIR-SHIELDS HILL-ROM PRODUCT SERVICE BULLETIN. REPLACE LAMPS ON PHOTOTHERAPY SYSTEMS MENTIONED ONLY BY NO. 1780745, WHICH ARE AS SPECIFIED BY HILL-ROM SERVICE MANUALS. INSTRUCTIONS ON THE REMOVAL AND REPLACEMENT OF THE LAMPS MAY ALSO BE FOUND IN SERVICE MANUALS. FOR FURTHER INFORMATION, PLEASE CONTACT YOUR AIR-SHIELDS HILL-ROM REPRESENTATIVE OR PHONE 1 (215) 675-5200 IN THE UNITED STATES.

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