09

Feb

2011

Cl ll Philips Patient Monitor M31250

0

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

PRODUCT
Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Information Center Software provides for the retrospective review of alarms, physiologic waves and parameters from its database. An additional intended use is to provide primary annunciation of alarms and configuration and control access for networked telemetry monitors. Recall # Z-0987-2011

REASON
Some PAS-201 active speaker assemblies in use with the Philips IntelliVue Information Center (PIIC) have experienced intermittent audio or loss of audio. Speaker failures may delay recognition of an alarm condition, if operators do not recognize that there is no alarm sound from the monitor and the monitor is not connected to another audible alarm annunciation system.

RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated December 17, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
1071

DISTRIBUTION
Nationwide and Canada

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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