Home / Recalls / Philips Electronics North America Corporation / Z-1440-2018

Z-1440-2018 Class II Terminated

Recalled by Philips Electronics North America Corporation — Andover, MA

Recall Details

Product Type
Devices
Report Date
April 25, 2018
Initiation Date
March 16, 2018
Termination Date
April 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
8,205 units in total

Product Description

T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

Reason for Recall

Potential risk for helium gas inside the MR examination room during a magnet quench

Distribution Pattern

Worldwide Distribution - US Nationwide; International - Albania, Algeria, Andorra, Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Barbados, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Chile, China, Colombia, Congo (Democratic Republic of the), Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kazakhstan, Kenya, Republic of Korea - South Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Lesotho, Libya, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macedonia, Malaysia, Malta, Mauritius, Mexico, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, Yemen & Zimbabwe.

Code Information

(Added 6/25/18): 4170 4113 4082 4176 4147 4319 4397 4285 4308 4408 4241 4064 4328 4312 4294 4296 4009 4274 4258 4297 4246 4200 4041 4207 4327 4318 4089 4102 4222 4025 4321 4177 4015 4088 4106 4260 4183 4272 4416 4365 4047 4411 4254 4301 4261 4307 4267 4386 4033 4099 4251 4339 4374 4162 4322 4320 4069 4006 4273 4418 4131 4194 4201 4152 4146 4095 4391

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