Recall Z-0199-2027 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216;
| Date | Oct 16, 2026 (initiated Sep 16, 2026) |
| Status | Open, Classified |
| Reason | Unreliable wireless roaming behavior of Smart-hopping 1.0 wireless clients during transport when connecting to Smart-hopping 2.0 infrastructure, resulting in loss of connectivity to the central monitoring system (PIC iX). |
| Root cause | Software design |
| Action | On september 16, 2026, URGENT Medical Device Correction, letters were sent to customers. Actions to be taken: 1. Direct clinical attendance of the patient during transport, when this issue is most likely to manifest, should be considered if not currently a part of the clinical workflow. In the event a persistent No Central Monit technical alarm is noted at the wireless device or a No Data technical alarm is noted at the central monitor; a restart of the wireless monitor may restore central monitoring when the patient is in known good wireless coverage area. 2. Pass this notice to all those |
| Quantity | 174 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.