Recall Z-1041-2022 ยท MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Philips North America Llc
Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3. For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.
| Date | Feb 22, 2022 |
| Status | Terminated |
| Reason | When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor. If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg. An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate. |
| Root cause | Under Investigation by firm |
| Action | An URGENT Medical Device Correction notification letter dated 2/18/22 was sent to customers. Actions that should be taken by the customer/ user in order to prevent risks for patients. Do not use the Non-Invasive Blood Pressure for Neonatal Patients until Philips has installed a new software revision that will solve this problem. Place this Urgent Medical Device Correction letter with the documentation of the Philips Hemodynamic Application until Philips implements the new software revision. Return the attached reply form to Philips to confirm that the users of the system have reviewed and un |
| Quantity | 77 |
| Distribution | Devices were distributed to the following US states: FL, ID, NJ, OK, SC and TX. Devices were distributed to the following foreign countries: France, Germany, India, Mexico, Netherlands, New Zealand, Norway, Poland, South Africa, and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181311 | Philips Hemodynamic Application R1.0 Philips Medical Systems Nederlands B.V., Sep 7, 2018 |