Recall Z-0545-2021 ยท DSI Detector And Alarm, Arrhythmia
Philips North America Llc
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
| Date | Nov 18, 2020 |
| Status | Terminated |
| Reason | Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient. |
| Root cause | Process control |
| Action | Philips North America issued Customer notifications on 11/18/2020 to US customers, via priority mail. Philips Market Organizations are responsible for distributing the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Philips is asking users to follow the Action to be Taken by Customer/User section of the FSN: Affected products may continue to be 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 sound from your X |
| Quantity | 2 units OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083517 | INTELLIVUE PATIENT MONITOR, MODELS MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80, AND MP90 Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, Jan 16, 2009 |