Home / Recalls / Philips North America Llc / Z-1863-2024

Z-1863-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
May 29, 2024
Initiation Date
May 3, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.

Code Information

UDI-DI: (01)00884838099746(21)42194 Serial Number: 42194

Other recalls by Philips North America Llc

  • Z-1315-2026 Class II — Brilliance iCT; Product Code (REF): 728306; (January 7, 2026)
  • Z-1318-2026 Class II — Spectral CT 7500 on Rails; Product Code (REF): 728334; (January 7, 2026)
  • Z-1317-2026 Class II — Spectral CT; Product Code (REF): 728333; (January 7, 2026)
  • Z-1316-2026 Class II — IQon Spectral CT; Product Code (REF): 728332; (January 7, 2026)
  • Z-1156-2026 Class II — Patient Information Center iX; Software Version Number: 4.5.0 (December 22, 2025)
  • Z-1033-2026 Class II — Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. (December 12, 2025)
  • Z-1210-2026 Class II — Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. M (December 3, 2025)
  • Z-1215-2026 Class II — SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with S (December 3, 2025)
  • Z-1208-2026 Class II — Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11. (December 3, 2025)
  • Z-1207-2026 Class II — Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW (December 3, 2025)