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

FDA device recall Z-2217-2011 · posted 2011-05-19 · Terminated

Recall details

Recalling firm

Philips Healthcare Inc.

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

Action taken

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

Status

Terminated

Product code

MHX

Quantity affected

15062 units

Distribution

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

Date initiated

2011-05-03

Date posted

2011-05-19

Date terminated

2017-04-25

Location

Andover, MA

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