Data Foundry

Medical device recalls 2024

SmartPath to dStream for 3 — Class II medical device recall Z-1861-2024

Ongoing recall by Philips North America Llc, reported 2024-05-29, distributed nationwide. The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may

Recall numberZ-1861-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America Llc, Cambridge, MA, United States
Recall initiated2024-05-03
Classified2024-05-17
Reported by FDA2024-05-29
DistributedNationwide (US)
Countries outside the USAT, BE, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HR, IT, JP, LB, LT, NL, NO, PL, RO, SE, SK, TH
Quantity3 units
Serial numbers17377, 34114, 38294
Model numbers782145

Product

SmartPath to dStream for 3.0T Model Number (REF): 782145

Reason for recall

The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire

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-1861-2024. 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.