Infinity Bedside Monitors Class II

REASON

Failure to correctly re-calculate drug dosage using saved Drug Dosage
Data.

PRODUCT

Infinity Modular Bedside Monitors, Models SC7000, SC8000, SC9000,
SC9000XL, intended for adult, pediatric, and neonatal monitoring of
clinical environment. Recall #Z-399/401-0.

CODE

Infinity Modular Monitors: SC7000, SC8000, SC9000, SC9000XL with
software versions VEO, VEO.1 or VEO.2

MANUFACTURER

Siemens Medical Systems, Inc., Danvers, Massachusetts.

RECALLED BY

Manufacturer, by letter dated February 15, 2000.
Firm-initiated field correction ongoing.

DISTRIBUTION

Arkansas, Arizona, California, Florida, Kentucky, Georgia, Illinois,
Michigan, New Mexico, New York, Ohio, South Dakota, Tennessee, Texas.

DISTRIBUTION

140 units were distributed.