Alerte De Sécurité sur 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.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Siemens Healthcare Diagnósticos S.A; Siemens Healthcare Diagnostics Inc..

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Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    2090
  • Date
    2016-10-24
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    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).
  • Cause
    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.

Manufacturer