Company: Olympus America, Inc.
Date of Enforecement Report: 3/7/01
Date of Recall: 10/1/99
Class: III

PRODUCT:

Integrated Endosurgery EndoALPHA Software Version 3.01.

Recall #Z-381-1.

REASON:

The device software version 3.01 prevented the control unit from
retaining the user-programmer coagulation setting.

CODE:

Catalog #UCES (Control Unit for Endosurgery), software version
3.01.

MANUFACTURER:

Olympus America, Inc., Melville, NY.

RECALLED BY:

Manufacturer, by letter and facsimile on October 1, 1999. Firm-
initiated recall complete.

DISTRIBUTION:

CA, VA, AL, and NV.

QUANTITY:

31.