Recall Z-2625-2010 ยท DSI Detector And Alarm, Arrhythmia
Philips Healthcare Inc.
Philips M3002A IntelliVue X2 Model: 865039 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment. ST segment monitoring is restricted to adult patients only. The M3002A and M810
| Date | Sep 29, 2010 (initiated Aug 31, 2010) |
| Status | Terminated |
| Reason | Speakers on the Philips IntelliVue X2 and MP2 patient monitors may fail, causing absence of an audible alarm and delaying patient treatment. |
| Root cause | Process design |
| Action | Philips issued a URGENT - MEDICAL DEVICE letter dated August 26, 2010, to each affected customer. The Urgent Medical Device Correction notification/Field Safety Notice informs customers of the issue and gives instructions on actions to take while awaiting their replacement speaker assemblies. The speaker replacement assembly is expected to be available in 8 weeks. Affected products may continue to e used while awaiting replacement of the speaker, provided that the user routinely checks for the display of the "Speaker Malfunct." INOP at power-up. If you experience this INOP or there is no soun |
| Quantity | 19,400 units |
| Distribution | Worldwide Distribution - USA and the countries of : ARGENTINA AUSTRALIA AUSTRIA BAHRAIN BANGLADESH BELGIUM BRAZIL CHINA CZECH REPUBLIC DENMARK EGYPT ESTONIA FINLAND FRANCE GERMANY GREECE HONG KONG HUNGARY ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KENYA KUWAIT LATVIA LIBYAN ARAB |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082633 | INTELLIVUE PATIENT MONITOR, INTELLIVUE XDS, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Oct 3, 2008 |