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Terminated

Philips Audio-Video Engineering PAS-210 Remote Active Speakers Kit used with the IntelliVue Information Center 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.

FDA Recall Z-2217-2011 · Posted 2011-05-19

Recalling FirmPhilips Healthcare Inc.
Recall StatusTerminated
Product CodeMHX
Date Initiated2011-05-03
Date Terminated2017-04-25
Product Quantity15062 units

Reason for Recall

PAS-210 Kit Remote Active Speaker Assembly used with the IntelliVue Information CenterSpeaker cable connection may lead to intermittent or loss of audio alarm annunciation

Firm Action

Philips Healthcare issued an Urgent - Medical Device Correction letter dated April 28, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to follow the "Action to be taken by Customer/User" section of the instructions while they await the correction, which will likely come in the form of a replacement audio cable for all affected speaker assemblies. For further information or support concerning this issue, please contact Philips Healthcare Customer Care Service Center at 800-722-9377 # 3, # 1 and reference the letter or your local Philips representative in your area.

Root Cause

Component design/selection

Distribution Pattern

Worldwide Distribution - USA (nationwide) and the country of Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081983M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00Philips Medical Systems · 2008-08-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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