Events

Safety Alert for 1. Acuson Antares Diagnostic Ultrasound System, Registry 10234230070; Series: 115454 /// 2. Aspen Dopple Ultrasonic System, Registry 10234230083; series: 32491 /// 3. Diagnostic system by ultrasonography sonoline G60 S, Registry 10234230086; series: GAA0313 /// 4. Cypress Diagnostic Ultrasound System, trademark Acuson, Registry 10234230097; The present invention relates to a Cardiovascular Ultrasound System CV70, trademark Acuson, registration number 10234230101, series: HAA0355, series: 83108, 73847, 73852, 74567, 75197, 82116, 82170, 82172, 82171, 82300, 80499, 82387, HAU0410, HAA0438, HAA0500, HAA0523, HAA0553, HAA0576 /// 6. Acuson Sequoia Doppler Ultrasonic System, Registry 10234230133, series: 64926, 64656, 64433 /// 7. Diagnostic Acuson X300 Ultrasound System, Registration 10234230141, series: 313087 ; 313098; 313160; 312133; 313-204; 313535; 313524; 313,504; 313529; 313555; 313722; 315272; 315255; 315262; 315297; 315547; 315487; 315588; 315611; 315778; 316036; 316601; 316585; 316680; 316811; 316818; 316866; 317282; 317485; 317545; 340495; 340496; 341851; 341896; 344505; 343232; 344650; 344717; 344723; 344724; 344733; 344734; 344815. /// 8. Diagnostic Ultrasound System Acuson SC2000, Registry 10234230166, series: 400762, 401809 /// 9. Acuson Diagnostic Ultrasound System. Entry 10234230192, series: 202637.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos Ltda.; Siemens Medical Solutios USA.

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
    1593
  • Date
    2015-05-18
  • 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
    According to the record holder, if the yellow tip protector continues to be used with the V5Ms transducer, its life may be shortened. //////// - 09/07/2015 - According to the company the Field Action was completed.
  • Reason
    The yellow tip protector of the transducer, shipped with the v5ms transducer, when not being used for exams, is covered by this protector. the shield is incompatible with the material covering the articulated portion of such a transducer, by coming into physical contact with one another.
  • Action
    The registry holder will perform a correction of the use instruction and recommends that users immediately stop using the yellow tip protector. After that, perform the leak test for the transesophageal transducer before each use, following the manufacturer's instructions accompanying the tester. Only use cleaning and disinfection solutions approved by the manufacturer. Use transducer sheaths released for the market and designed specifically for transesophageal applications. When storing the transesophageal transducer, take extreme care to keep the distal tip upright. Never move the distal tip by hand. Always use the flexible controls. If you notice any damage or wear on your transducer, or if the transducer does not pass the leak test, immediately stop its use and contact your local Service Engineer.

Device

1. Acuson Antares Diagnostic Ultrasound System, Registry 10234230070; Series: 115454 /// 2. Aspen...

Manufacturer

Siemens Healthcare Diagnósticos Ltda.; Siemens Medical Solutios USA
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA