Data Foundry

Medical device recalls 2026

Philips Smart-hopping 2 — Class II medical device recall Z-1033-2026

Ongoing recall by Philips North America Llc, reported 2026-01-14, distributed nationwide. It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident

Recall numberZ-1033-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America Llc, Cambridge, MA, United States
Recall initiated2025-12-12
Classified2026-01-08
Reported by FDA2026-01-14
DistributedNationwide (US)
Quantity13,470 units
Reason classespotency
UPC / GTIN / UDI-DI00884838099876
Model numbers867216

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1033-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.