Recall Z-1182-2007 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Medical Systems
Intellivue Central Station Software for the: Intellivue Information Center; Philips Information Center, Central Station Models: M3145, M3150, M3154, M3155, M3169
| Date | Sep 5, 2007 (initiated Jul 16, 2007) |
| Status | Terminated |
| Reason | Incorrect Patient Assignment: the information center will in most cases be associated with the "incorrect" patient. This occurs on both standalone and networked systems running fixed mode monitoring. (This does not occur on systems that run flex mode monitoring) |
| Root cause | Other |
| Action | Philips Medical Systems issued a letter notification dated July 2007 " Urgent Device Correction". Customers with networked information centers will be corrected through a database server. Stand-Alone units will have a software correction. Software version J.00.25 will correct the problem. Users are advised not to use th 12 Lead Analysis and Export Option in fixed or flex mode monitoring unitl the software correction is made. |
| Quantity | 76 units |
| Distribution | Worldwide Distribution: USA including states of NJ, NY, OK, MI, and UT and Foreign: Australia, Finland, France, Netherlands, and the UK |
| 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 |