Cl ll Philips IntelliVue

Company: Philips Healthcare Inc.
Date of Enforcement Report 2/2/2011
Class ll:

PRODUCT
Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03. Recall # Z-0414-2011.

REASON
Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions not being generated after the first 24 hours.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Philips Healthcare Inc., Andover, MA, by letter dated October 15, 2010.
Manufacturer: Philips Medizin Systeme Boblingen Gmbh, Boblingen, Germany. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
200

DISTRIBUTION
Nationwide and Internationally

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