05

Mar

1999

Philips Sonodiagnost 800 Class II 145 units

0

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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