Recall Z-2217-2011 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Healthcare Inc.
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
| Date | May 19, 2011 (initiated May 3, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Component design/selection |
| 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 |
| Quantity | 15062 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081983 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE 1.00 Philips Medical Systems, Aug 22, 2008 |