Home / Recalls / Philips North America Llc / Z-0393-2024

Z-0393-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

Recall Details

Product Type
Devices
Report Date
November 29, 2023
Initiation Date
October 23, 2023
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
102 units

Product Description

Intera 1.5T

Reason for Recall

Potential component failure in the Gradient Coil could product smoke and/or fire.

Distribution Pattern

Domestic: Nationwide Distribution; Foreign: Albania, Andorra, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bolivia, Bosnia, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Libya, Luxembourg, Malaysia, Malta, Mexico, Myanmar, Nepal, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Poland, Portugal, Puerto Rico, Romania, Russian Fed., Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sudan, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, UAE, Venezuela, Vietnam, & Yemen.

Code Information

Product No. 781195 & 781295; UDI-DI: N/A; Serial No. 18510, 18516, 18529, 18550, 18564, 18567, 18578, 18583, 18592, 18657, 18660, 18667, 18678, 18701, 18709, 18711, 18714, 18725, 18727, 18769, 18773, 18776, 18787, 18812, 18820, 18854, 18856, 18857, 18870, 18873, 18878, 18884, 18889, 18890, 18905, 18906, 18907, 18913, 18917, 18920, 18923, 18931, 18935, 18947, 18948, 18950, 18965, 18973, 18986, 18998, 20402, 20403, 20404, 20409, 20426, 20441, 30004, 30030, 30037, 30038, 30064, 30079, 30081, 30082, 30131, 30187, 30190, 30199, 30200, 30206, 30213, 30218, 30219, 30223, 30234, 30235, 30236, 30238, 30255, 30256, 30265, 30266, 30267, 30268, 30272, 30274, 30277, 30278, 30279, 30280, 30281, 30284, 30285, 30288, 30293, 30296, 30297, 30298, 30303, 30311, 30312, 30315.

Other recalls by Philips North America Llc

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  • 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)