Company: Philips Healthcare, Inc
Date of Enforcement Report 6.17/2009
Class:ll

PRODUCT
CareVue Chart Release C.O Part Number: 862246 Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage. Recall # Z-1436-2009

REASON
A software defect under certain circumstances could lead to the unintended administration of a duplicate dose of a scheduled medication within a single 24 hour period.

RECALLING FIRM/MANUFACTURER
Philips Healthcare, Inc., Andover, MA, by letter on May 6, 2009. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
103 units

DISTRIBUTION
CA, FL, MA, OH, OK, RI, VT, and WV and countries of Canada, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, and the United Kingdom