Device product
Intera 1.5T
Z-0393-2024
Product summary
- Event
- Event 93361
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 102 units
- Official record key
device-enforcement:Z-0393-2024
Official wording
Reason: Potential component failure in the Gradient Coil could product smoke and/or fire.
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.
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.
Derived failure modes
-
Unknown
Potential component failure in the Gradient Coil could product smoke and/or fire.