Events

Safety Alert for : PHOTOTHERAPY SYSTEMS: (1) MODEL PTL68, (2) MODEL PTM78, (3) MODEL PTS68; (4) PHOTOTHERAPY SYSTEM LAMPS. PARTS: (1 to 3) UNIDENTIFIED, (4) 1780745

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by HILL-ROM AIR-SHIELDS A HILLENBRAND CO.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    119
  • Date
    2000-09-29
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    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.
  • Reason
    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.

Device

: PHOTOTHERAPY SYSTEMS: (1) MODEL PTL68, (2) MODEL PTM78, (3) MODEL PTS68; (4) PHOTOTHERAPY SYSTE...

Manufacturer

HILL-ROM AIR-SHIELDS A HILLENBRAND CO
  • Source
    ANVSANVISA