medical Class II Updated 2018-04-25

Philips Electronics North America Corporation recalls T5-NT, Model 78104 Product Usage: Indicated for use as a

Recalled Product

T5-NT, 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.

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: (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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