Recall Z-2528-2017 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. 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 secon
| Date | Jun 13, 2017 (initiated Dec 17, 2010) |
| Status | Terminated |
| Reason | Potential for early component failure. |
| Root cause | Component design/selection |
| Action | Philips sent an Urgent Medical Device Correction letter dated December 17, 2010, to all affected consignees. Philips will replace defective system boards in Hewlett Packard model rp5700 PCs sold with IntelliVue Information Centers to correct the problem. Philips Healthcare representatives will inspect all affected units, and any unit identified to have a defective system board will have its system board replaced at no charge to the customer. Philips is asking the following of customers in the Action to be Taken by Customer/User section of the FSN: Observe your system for any of the symp |
| Quantity | 607 units |
| Distribution | Worldwide Distribution - US (Nationwide) OUS: CANADA ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BELGIUM BRAZIL CHILE CHINA COLOMBIA CZECH REPUBLIC FINLAND FRANCE GERMANY GREECE INDIA INDONESIA IRELAND ITALY JAPAN KENYA KOREA, REPUBLIC OF NETHERLANDS PHILIPPINES POLAND SPAIN SWE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K062271 | M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170) Philips Medical Systems, Nov 30, 2006 |