FDA Recall Open, Classified

Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

Recall: Z-1033-2026 · Initiated December 12, 2025

Recall

Recall Number
Z-1033-2026
Event Number
98158
Firm
Philips North America Llc
FEI Number
3016618143
Product Code
MHX
Status
Open, Classified
Root Cause
Software design
Initiated
December 12, 2025
Posted
January 8, 2026
Address
222 Jacobs St, Cambridge, MA, 02141-2289

Description

Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.

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.

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 questions should contact their local Philips representative or call 1-800-722-9377.

Distribution

US Nationwide distribution.

Quantity

13,470 Units