Home / Recalls / Philips Electronics North America Corporation / Z-1432-2018

Z-1432-2018 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

Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 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): 7149 7210 7082 7212 7015 7174 7081 10327 7073 10332 7063 7040 7119 7095 7272 10104 7005 7213 7057 10326 7128 10339 7230 10329 7183 7098 10053 7080 7011 7178 7139 7126 10192 7217 7066 7171 7136 7038 7050

Other recalls by Philips Electronics North America Corporation

  • Z-0614-2019 Class II — Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6. (November 15, 2018)
  • Z-0592-2019 Class II — IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Pro (October 10, 2018)
  • Z-3235-2018 Class II — Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and (July 16, 2018)
  • Z-3228-2018 Class II — AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3232-2018 Class II — Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and n (July 16, 2018)
  • Z-3237-2018 Class II — Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and ne (July 16, 2018)
  • Z-3213-2018 Class II — INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovasc (July 16, 2018)
  • Z-3236-2018 Class II — Allura Xper F020 Biplane DR Table, System Code 722020 Vascular, cardiovascul (July 16, 2018)
  • Z-3238-2018 Class II — Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular a (July 16, 2018)
  • Z-3239-2018 Class II — Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and (July 16, 2018)