Events

Safety Alert for ELECTRODE ADAPTERS, CABELUDO LEATHER, FETAL, SAFECONNECT DECG MODEL M1347A; ADAPTERS USED TO CONNECT THE ADAPTER CABLE TO THE SAFECONNECT DECG LEG PLATE, MODEL M1362B, TO THE DECG MODEL TRANSDUCER MODEL M1357A (FOR AGILENT / HP PHOTOS 50 SERIES 50: MODELS M1350A, B, C; M1351A; E M1353A) AND MODG TRANSDUCER MODEL 15240A (FOR AGILENT / HP FACTORY MONITORS MODEL 8040A). ADAPTERS WITHOUT DATE OR CODE.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by AGILENT TECHNOLOGIES INC..

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
    75
  • Date
    2001-05-11
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The electrical connection is low between adapters and other accessories to measure the electrocardiography, which may cause losses or interference of the electrocardiographic sign, ecg, which may result in the inability to monitor the rate of fitness heart beatings. the distributor began removal and replacement by letter sent in december.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE DECEMBER 2000 LETTER, WITH THE NEWS OF URGENT REMOVAL AND REPLACEMENT WITH THE NEW ADAPTERS FOR MODEL M1347A, WITH CODE AND DATE, LABELS FOR RETURN AND ENVELOPES OF AGILENT. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. REPLACE ADAPTERS AFFECTED WITH NEW SENDERS. RETURN AFFECTED REPLACEMENTS USING ENVELOPES AND LABELS AS INDICATED. FOR FURTHER INFORMATION OR IF YOU WISH TO COMMUNICATE THAT YOU DO NOT HAVE ANY OF THE PRODUCTS AFFECTED, CONTACT AGILENT NO 0021-1-880-668-4391

Device

ELECTRODE ADAPTERS, CABELUDO LEATHER, FETAL, SAFECONNECT DECG MODEL M1347A; ADAPTERS USED TO CONN...

Manufacturer

AGILENT TECHNOLOGIES INC.
  • Source
    ANVSANVISA