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March 5, 1999

TO: Hospital Administrator or Risk Manager

SUBJECT: Philips Medical SD800 Diagnostic Ultrasound System, Manufactured and Serviced by Hewlett-Packard Company ("HP")

Important: Please inform all clinical users of this medical device of the content of this letter.

Reason for recall:

HP has found that when the Philips Medical SD800 Ultrasound System is used with the Philips Model EV7014 Endovaginal Transducer to perform a needle biopsy, the biopsy guiding graphic overlay generated by the system software incorrectly indicates the track of a needle held in the biopsy guidance attachment.

The graphic overlay indicates a track that is 90 degrees from the actual orientation of the needle. Users normally visualize the actual image of the needle and would therefore note that its orientation does not coincide with the overlay graphic before proceeding with the biopsy.

The User's Guide specifically cautions users against using the overlay graphic as an absolute reference. However, should the user nevertheless rely on the overlay graphic as the sole guide, the needle may penetrate and potentially damage unintended target tissue, causing bleeding or other complications, and if a fetus is present in the uterus, result in fetal injury or death.

The EV7014 Endovaginal Transducer and related guiding graphics are only supported when the SD800 is operated with system software version 2.1 or 2.1.1. This problem only affects users of such systems who use the EV7014 Endovaginal Transducer to perform needle biopsies, and it does not affect any other use of application of the SD800.

Recommendations:

Do not use the needle biopsy guiding graphics feature of your SD800 to perform needle biopsies using the EV7014 Endovaginal Transducer until your HP representative has installed upgraded system software.

HP Actions:

HP is in the process of revising the SD800 system software. It will install the upgraded system software at no cost in all SD800 systems currently running system software version 2.1 or 2.1.1. Your HP representative will contact you after April 2, 1999 to install the revised software. The revised software will allow you to resume using the needle biopsy guiding feature of your SD800 system to perform needle biopsies using the EV7014 Endovaginal Transducer .

Hewlett-Packard regrets any inconvenience that this recall may cause. Your satisfaction with HP products and service is of the utmost importance to us.

Sincerely,

Hewlett-Packard Company

Greg Petras
General Manager
Imaging Systems Division