Recall Z-0686-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216
| Date | Dec 17, 2024 (initiated Nov 20, 2024) |
| Status | Open, Classified |
| Reason | The following four issues are included: 1. Certain Channel Settings may result in an Access Point preventing a connected client device from roaming to another Access Point potentially causing the client device to appear to drop out from the network. 2. if the Access Point experiences a disconnection from the Access Point Controller exceeding 4 minutes, the Access Point may not transition through the desired state to all for clean reconnection of the client radio link. 3. Potential to experience higher than expected data dropouts, device disassociations/reassociations for their wireless cl |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified on about 11/20/2024 via certified mail. Consignees were instructed to identify affected units, share the communication with clinical staff, and place the Urgent Medical Device Correction with the documentation of the Philips Smart-hopping 2.0 AP 1.4 GHz and associated devices. A Philips representative will contact customers to arrange a software upgrade to E.19.02 (5.0.19.02) or greater to correct the issues. Distributors were instructed to contact customers and provide the Medical Device Correction to each. |
| Quantity | 4,811 units |
| Distribution | Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.