Events

Safety Alert for ACUSON Ultrasound Diagnostic System Technical Name: Ultrasound Apparatus ANVISA Registration Number: 10345162017 Hazard Class: II Affected Model: ACUSON S1000, ACUSON S2000, ACUSON S3000 Series Affected Numbers: 201092, 201936, 202290, 202295 , 202352, 202637, 203198, 203217, 203217, 203217, 203217, 203282, 203531, 203535, 203549, 203559, 205259, 205260, 205262, 205282, 205344, 205494, 205521, 205572, 205651, 205701, 205750, 205876, 206270 , 206756, 206984.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics 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
    2090
  • Date
    2016-10-24
  • 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
    To avoid the problem of misalignment of the transducers the recommendation is not to use the 6C1 HD and 18L6 HD transducers with the CIVCO biopsy connectors for guided biopsy procedure. Guided procedures should be performed with other transducers as stated in the "Instructions for Use" of the equipment. To avoid the problem of repositioning Virtual Touch IQ, you should not reposition the region of interest of the original location (default).
  • Reason
    The company has identified in acuson s family systems that both the 6c1 hd transducers and the 18l6 hd transducers demonstrate an alignment error when using the screen orientations. this problem occurs when using the civco biopsy connectors in combination with the acuson s family screen orientations. the path of the biopsy needle may not match the orientation of the screen. this occurs on 6c1 hd and 18l6 hd transducers. a possible measurement error on the acuson s family ultrasound system when repositioning the virtual touch iq region of interest from its original (standard) location is also described, the lateral position of the measuring tool may not be in line with the lateral position of the shear velocity data.
  • Action
    Field Action Code US007 / 16 / S triggered under the responsibility of the company Siemens Ltda. Company will make correction in the field.

Device

ACUSON Ultrasound Diagnostic System Technical Name: Ultrasound Apparatus ANVISA Registration Numb...

Manufacturer

Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    ANVSANVISA