Home / Recalls / Philips North America Llc / Z-3205-2024

Z-3205-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
October 2, 2024
Initiation Date
September 3, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

SmartPath to Ingenia Elition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782118

Reason for Recall

Integrated Radio Frequency (IRF) Carrier assembly screws may come loose and protrude beyond the surface could cause the screws to interfere with other moving parts, potentially blocking the horizontal tabletop. May lead to delay in diagnosis and/or may include anxiety of a patient is left on the tabletop inside the bore for a longer duration than anticipated. movement.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Iceland, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Maldives, Mauritius, Mexico, Morocco, Netherlands, Pakistan, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Thailand, T¿rkiye, United Kingdom, Utd.Arab.Emir., Uzbekistan, Vietnam.

Code Information

UDI-DI: (01)00884838099746(21) Serial Numbers: 85661 85676

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  • 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)