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

Z-0393-2024 Class II Ongoing

Recalled by Philips North America Llc — Cambridge, MA

FDA device recall Z-0393-2024 was initiated by Philips North America Llc on October 23, 2023 and is designated Class II. Reason for recall: Potential component failure in the Gradient Coil could product smoke and/or fire. The recall status is ongoing. Affected quantity: 102 units.

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

  • Z-2579-2026 Class II — Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the follo (June 5, 2026)
  • Z-2523-2026 Class II — Philips Avalon Fetal Monitor, FM 30 Part numberM2703A (May 26, 2026)
  • Z-2522-2026 Class II — Philips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703A (May 26, 2026)
  • Z-2354-2026 Class II — DigitalDiagnost C90 Flex/Value/Chest/ER. Model Number: 712035. (May 1, 2026)
  • Z-1955-2026 Class II — Philips Evolution upgrade 3.0T with MR Elastography (MRE). 1. Model Number ( (April 14, 2026)
  • Z-1960-2026 Class II — Philips Ingenia Ambition S with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)
  • Z-1966-2026 Class II — Philips SmartPath to dStream for 3.0T with MR Elastography (MRE). 1. Model N (April 14, 2026)
  • Z-1963-2026 Class II — Philips Ingenia Elition X with MR Elastography (MRE). 1. Model Number (REF): (April 14, 2026)
  • Z-1961-2026 Class II — Philips Ingenia Ambition X with MR Elastography (MRE). 1. Model Number (REF) (April 14, 2026)
  • Z-1965-2026 Class II — Philips SmartPath to dStream for 1.5T with MR Elastography (MRE). 1. Model N (April 14, 2026)

FDA data resources