Recall Z-0856-2016 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips Electronics North America Corporation
Philips Healthcare IntelliVue Info Center iX, A.0 866023
| Date | Feb 23, 2016 (initiated Nov 25, 2015) |
| Status | Terminated |
| Reason | Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. |
| Root cause | Software Design Change |
| Action | Philips Healthcare issued a Field Safety Notice on 11/25/15 to inform customers of the issue, identifies details of the units affected, gives instructions on actions to be taken by the customer and identifies what action Philips plans to take to remedy the issue.Philips will provide a software correction free of charge. On 1/28/16 the Philips issued an updated letter to users.Philips has initiated a correction to address this issue. A software correction will be provided to customers with impacted devices at no charge. Philips is asking customers to follow the Action to be Taken by Customer/ |
| Quantity | 5671 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Algeria Australia Austria Belgium Bulgaria Canada Denmark Estonia Finland France Germany Hong Kong Hungary Iceland India Indonesia Iraq Ireland Israel Italy Japan Kenya Korea Kuwait Luxembourg Malaysia Mongolia Morocco Netherlands New Zeal |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102495 | M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0 Philips Medical Systems, Sep 30, 2010 |