Recall Z-3192-2018 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Invivo Corporation
Xper Flex Cardio Physiomonitoring System Model # 453564669081 Software Version 1.6.0.0388
| Date | Aug 3, 2018 |
| Status | Terminated |
| Reason | Released with an incorrect, older firmware version installed. May result in intermittent loss of ECG monitoring, inaccurate ECG amplitude display and or auxiliary output, and inaccurate heart rate (HR) displayed due to QRS detection fault. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | Philips is asking customers to follow the Action to be Taken by Customer/User section of the August 3, 2018, Field Safety Notice: The Field Safety Notice informs 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 replace all affected devices. Users should discontinue use of affected devices immediately. A Philips representative will contact you regarding your affected device. |
| Quantity | 38 |
| Distribution | Distribution in the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101571 | XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS Witt Biomedical Corp, Oct 26, 2010 |