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Open, Classified

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

FDA Recall Z-1033-2026 · Posted 2026-01-08

Recalling FirmPhilips North America Llc
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2025-12-12
Product Quantity13,470 Units

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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