Events

Safety Alert for ULTRASOM, PORTATIL

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SON SITE 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
    93
  • Date
    2001-08-22
  • 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 IS NOT REGARDING PRODUCT REGISTRATION IN BRAZIL (SONOSITE INC. MANUFACTURER)
  • Reason
    The system contains an estimated date calculation error when using the nyberg obstetric calculator algarithm. the first of the 3 measures attributed gestacional saco (sg) is used to estimate of the expected date of department (dpp). sono site affirms that this situation does not present risk to the operator and the patient, since payments are not used to make decisions on patient health or fetal vitality in the first quarter of pregnancy.
  • Action
    THE MANUFACTURER BEGAN CORRECTION BY LETTER OF MAY 4, 2000 A FOLLOW UP LETTER WAS SHIPPED ON AUGUST 31, 2000. VERIFY THAT YOU HAVE RECEIVED THE SLEEP LETTER SITE CONTAINING THE UPDATE OF THE SOFTWARE MODULE P 01569-01, THE INSTRUCTIONS TO COMPLETE THE UPDATE (P 01691-01), THE LIST OF PARTS NUMBERS, THE NEW USER'S GUIDE DESCRIBING THE NEW FUNCTIONS OF THE UPDATED SYSTEM 9P 0719-05) AND THE PRE-PAYED PACKAGE TO RETURN THE OBSOLETE MODULE. TO CONFIRM THAT YOUR MODULE 180 OF THE SYSTEM IS AFFECTED: 1 - SEE THE LABEL BELOW THE SYSTEM AND ENTER THE PART NUMBER (PO XXXX); 2 - ACCESS THE MONITOR, THE INFORMATION SYSTEM, PLACE THE SYSTEM "ON", TIGHTEN THE "FUNCTION" KEY, AND KEY "I" AND CHECK THE SOFTWARE VERSION INDICATED ON THE "ARM VIEW" LINE OF THE MONITOR. 3- IF THE PART NUMBER AND THE COMBINED ARM VERSION WERE EQUAL TO WHICH ARE PRESENTED ON THE LIST ABOVE, DO NOT USE THE NYBERG GS OBSTETRIC ALGARITHM TO CALCULATE DPP. AS SOON AS POSSIBLE, COMPLETE THE SYSTEM UPDATE, PLACE THE OBSOLETE MOCLEAR IN THE PRE-PAYMENT PACKAGE OR PICK THE PRE-PAYED LABEL INTO THE ORIGINAL BOX, WATERPROOF, PLACING ON A PLASTIC AND NOTIFY THE UPS TO PICK THE PACKAGE. SONO SITE RECOMMENDS THAT THE CALCULATION ALGARITHM OF THE DPP IS NOT USED UNLESS IT IS UPDATED. FOR FURTHER INFORMATION, CONTACT THE SLEEP TECHNICAL SUPPORT ON THE PHONE (877)657-8118 OR (425) 951-1030 E-MAIL SERVICE@SONOSITE.COM

Device

ULTRASOM, PORTATIL

Manufacturer

SON SITE INC
  • Source
    ANVSANVISA