Recall Z-1926-2024 · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.
| Date | May 30, 2024 (initiated May 2, 2024) |
| Status | Open, Classified |
| Reason | Potential for pressure wave data synchronization from two devices may not be correct. |
| Root cause | Component design/selection |
| Action | Consignees were mailed an URGENT Medical Device Correction notice, dated 4/30/24. Consignees are instructed to keep the provided notification with the documentation of affected systems until Philips implements the software correction, follow the provided instructions when connecting the pressure wire to the FM-PIM and refer to the FM Patient Interface Module (Option Manual, Chapters 3 and 5), and circulate the provided notification to all users of the system. In the case that steps described in the notification are not executed and/or the described issue is observed, perform the normalization |
| Quantity | 391 units |
| Distribution | Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, N |
| 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 |