Data Foundry

Medical device recalls 2024

Ingenia Ambition X- Magnetic Resonance — Class II medical device recall Z-1851-2024

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-1851-2024
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
Quantity509 units
UPC / GTIN / UDI-DI00884838090040, 00884838098350, 00884838108622
Serial numbers47000, 47001, 47002, 47003, 47004, 47006, 47007, 47009, 47011, 47012, 47013, 47014, 47015, 47016, 47017, 47018, 47019, 47020, 47021, 47022, 47023, 47024, 47025, 47026, 47027 and 475 more
Model numbers781356, 782109, 782138

Product

Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356

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-1851-2024. 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.