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.
