Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. (Philips North America Llc) – it was found that the mx40 device cou... (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.