Philips Medical Sonodiagnost 800, intended for endovaginal biopsy for various gynecologic and obstetric procedures including follicular retrieval, endometrial biopsy, and fluid aspiration of any type in a potentially pregnant patient. Recall #Z-772-9.
REASON
Software used with Transducer EV7014 incorrectly indicates track of the biopsy needle.
CODE
All SD800’s with Software versions 2.1. and 2.1.1 used with
Endovaginal Transducer EV7014, serial numbers are as follows:
3424A00105 3434A00109 3434A00133 3441A00122 3441A00130
3510A00142 3510A00145 3510A00185 3510A00188 3514A00160
3514A00168 3527A00052 3527A00204 3624A00471 3640A00626
3728A00051 3728A00120 3728A00165 3728A00519 3728A00611
3728A00612 3728A00614 3728A00635 3728A00637 through
3728A00750, 3728A00752 through 3628A00756.
MANUFACTURER
Hewlett-Packard Company, Andover, Massachusetts
RECALLED BY
Manufacturer, by letter dated March 5, 1999. Firm-initiated recall ongoing.
DISTRIBUTION
Nationwide.
QUANTITY
145 units were distributed.
