Recall Z-0451-2008 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Medical Systems
Philips Medical Systems, M3290A IntelliVue Information Center Software for M3170 Intellivue Patient Link, Catalog Number: 865007 and 865015; Running Software Versions J.00.23, J.00.24, J.00.25, and J.00.26, Manufactured and Distributed by; Philips Medical Systems, Andover, MA 01810
| Date | Dec 11, 2007 (initiated Nov 13, 2007) |
| Status | Terminated |
| Reason | Alarm failure : If changes are made to the Caregroup Editor configuration, Care Group alarm status, including alarm text and prompt tones, may fail to be displayed or annunciated at bedside monitors within the Care Group |
| Root cause | Software change control |
| Action | Philips Medical notified customers by letter dated November 2007 titled : Urgent Medical Device Correction Notice. Customers will be instructed to follow the Procedure to Mitigate Risk section * of the notice while they await the correction of their devices with a mandatory software upgrade to be performed by service representatives. * (no changes are to be made to the Caregroup Editor configuration on any system. If changes have already been made to the configuration prior to receipt of this notification, turn each bedside monitor "off " and then "on" in order to reset the system-Customer |
| Quantity | 60 units |
| Distribution | Worldwide Distribution -USA including states of CA, MA, TX, IN, MI, FL, MN, NC, MS, HI, RI, NH, and PA, and countries of Canada, Australia, Belgium, France, Germany, Ireland, Italy, Japan, Switzerland, United Arab Emirates, and The United Kingdom. |
| 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 |