Recall Z-1033-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Philips North America Llc
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
| Date | Jan 8, 2026 (initiated Dec 12, 2025) |
| Status | Open, Classified |
| Reason | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly. |
| Root cause | Software design |
| Action | An URGENT Medical Device Correction notice, dated December 2025, was mailed to consignees. Risk mitigations to prevent the failure of devices to transmit data to central stations via the Smart-hopping network are outlined in the provided notification. The notice instructs consignees to share the provided communication with all clinical staff to review and understand, and to place the notice with documentation for affected devices. A Philips representative will contact consignees to arrange a software upgrade to E.10.03 (5.0.19.3) or greater, to correct the recall issues. Consignees with any qu |
| Quantity | 13,470 Units |
| 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.