Company: Philips Medical Systems
Date of Enforcement Report 9/3/2008
Class:ll

PRODUCT
a) CareVue Chart Release C ,Versions C.00.00 through C.00.06 Product No. 862246.
This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage, Recall # -1540-2008;
b) IntelliVue Clinical Information Portfolio Critical Care Release D, Version D.00.00
Product Number: 865047. This device is a clinical information system intended for use in data collection, storage, and management with independent bedside devices, and other systems that are connected either directly or through networks. It is used when there is a need for generating patient records and computation of drug dosage, Recall # Z-1541-2008

REASON
Medications prescribed for one patient were printed on the record of another patient.

RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Andover, MA, by letter dated February 29, 2008. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
138 units

DISTRIBUTION
Nationwide and internationally