PHILIPS SD800 System Ultrasound Transducer

HP has found that when the doctor SD800 Philips Ultrasound System used with the Philips Model EV7014 endovaginal transducer for biopsy needle, guided biopsy graphic overlay generated by the system software incorrectly indicates the track of a needle held in the biopsy attachment orientation.

The graphic overlay indicates a track that is 90 degrees from the actual orientation of the needle. Typically users to view the real image of the needle and therefore does not notice that its orientation coincides with the graphic overlay prior to biopsy.

The User's Guide specifically warns users against the use of graphical overlay as an absolute reference. However, if the user however, rely on the graphic overlay as the only guide, the needle can penetrate and potentially damage the unwanted target tissue, causing bleeding or other complications, and if present a fetus in the uterus, resulting in injury or stillbirth.

The endovaginal transducer and graphics EV7014 related guidance only supported when the SD800 is operated with the system software version 2.1 or 2.1.1. This problem only affects users of these systems using the EV7014 endovaginal transducer for needle biopsy, and does not affect any other use of the application of the SD800.

recommendations:

Do not use the needle-guided biopsy of the SD800 charts for needle biopsies using the endovaginal transducer EV7014 until your HP representative has installed the system software updated.

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