ACUSON S Family Ultrasound Systems utilising the 18L6 HD and/or 6C1 HD biopsy guidelines 의 리콜

Recall

RC-2015-RN-00609-1

Class II

2015-07-07

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00609-1

This issue occurs when using the civco biopsy attachments in combination with the acuson s family on-screen guidelines. the biopsy needle may traverse outside the on-screen guidelines. this occurs on the 6c1 hd and 18l6 hd transducers. the potential risk is the tissue of interest may not get sampled. to date, no patient injury has been reported.

To avoid this issue, users are advised not to use the 6C1 HD and 18L6 HD with the CIVCO biopsy attachments for guided biopsy procedures. For guided procedures with other transducers, users are advised that they must verify that the path of the needle is accurately indicated by the on-screen guidelines. The needle guide is ready for patient use only after the path of the needle has been verified. Also, users are reminded of the following warnings: - The biopsy guidelines that display on the system monitor are not intended as an absolute reference. It is the user's responsibility to verify correct positioning of the needle during a biopsy or puncture procedure. - Do not use a needle guide if the path of the needle is not accurately indicated by the on-screen guidelines. The path of the needle must display within the guideline. Users are advised to contact their Siemens service representative if the needle path is not accurately indicated.