Home / Recalls / Philips Electronics North America Corporation / Z-1442-2018

Z-1442-2018 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

T5 Model 78104 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): 561 548 719 734 698 681 541 830 563 717 852 633 574 929 741 942 572 697 649 544 757 647 725 888 516 818 682 537 747 718 751 726 769 502 625 514 761 778 577 554 848 560 624 527 525 523 773 670 532 620 593 558 793 616 505 758 636 672 823 947 590 540 724 653 801 568 646 855 576 545 580 581 506 693 559 551 925 612 623 530 777 917 907 831 652 613 632 675 849 604 944 820 920 650 539 654 941 928 713 657

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