Devices

Device Recall AXIS

  • 모델명 / 제조번호(시리얼번호)
    Model #: 882130; Serial #: 541
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution-US (nationwide) including DC & Puerto Rico and the following countries: Albania, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cambodia, Cameroon, Cayman Islands, China, Colombia, Democratic Congo, Croatia, Cuba, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Georgia, Germany, Ghana, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Kuwait, Kyrgyzstan, LAO People's Dem. Rep., Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malawi, Malaysia, Malta, Mauritius, Monaco, Mongolia, Morocco, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Philippines, Poland, Portugal, R¿union, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia & Montenegro, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, Vietnam, Yemen, and Zambia.
  • 제품 설명
    AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
  • 1 Event

제조사

Philips Medical Systems (Cleveland) Inc
  • 제조사 주소
    Philips Medical Systems (Cleveland) Inc, 595 Miner Rd, Cleveland OH 44143-2131
  • 제조사 모회사 (2017)
    Philips
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건

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Device Recall AxisShield Liquid Stable (LS) 2Part Homocysteine Assay
  • 모델명 / 제조번호(시리얼번호)
    Part Number/Lot Number: FHBC100/802899574; FHRWR100/802899249; FHRWR1000/802899248; FHRWR200/802899989; FHRWR200/802899250; FHRWCN1/802900104
  • 의료기기 분류등급
    Clinical Chemistry and Clinical Toxicology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide in the states of: KY, WA, CA, and PA and the country of Germany.
  • 제품 설명
    Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT; 100 test format, 1000 test format, and 200 test format; and Private Label: (Distributed by BECKMAN COULTER, for professional use only, on the BECKMAN COULTER AU platforms (AU400, AU480, AU680 and AU5800)) || Product Usage: || For in-vitro quantitative determination of total homocysteine in human plasma or serum.
  • Manufacturer
    Axis-Shield Diagnostics, Ltd.
Device Recall AXIS SPECT Systems & IRIX SPECT Systems
  • 모델명 / 제조번호(시리얼번호)
    System Code #, 882130, Serial #, 10, 97, 101, 103, 104, 107-112, 116, 117, 119-121, 123, 125, 127, 130, 132, 133, 135, 138, 142-144, 149-151, 153-158, 162-164, 166, 169-173, 180, 181, 185, 186, 189, 193-204, 214, 215, 218, 219, 221-223, 227, 229-231, 233-237, 240, 242, 244-246, 249-251, 260-262, 264, 267, 272, 273, 275, 277, 280, 281, 283, 285, 291-293, 295, 297-300, 305, 308-310, 312, 316, 319-322, 326-332, 334-336, 338-340, 346, 347, 349, 351, 352, 354, 355, 358-363, 368-370, 374, 377-379, 385, 387, 388, 390-396, 401-407, 411, 412, 416-419, 426-432, 434, 437, 438, 442, 443, 445-447, 449, 452, 457-462, 464, 465, 468, 471, 474, 480-485, 487, 490-493, 495, 496, 499, 502, 503, 505, 508, 509, 511, 513-518, 520, 521, 523, 529, 530, 534, 543-546, 548-560, 562, 563, 569-572, 574-576, 580, 582, 583, 585, 586, 590, 594, 595, 597, 602-607, 611, 612, 618-621, 624-628, 630, 635, 636, 640, 641, 647-650, 654, 656-658, 660-665, 668-673, 675, 679, 681-684, 686, 687, 690-695, 697-699, 701-708, 711-719, 723-729, 733-736, 738, 739, 743-746, 749-753, 755, 756, 759, 760, 762, 764-767, 771-773, 776-778, 780, 781, 786, 789, 790-795, 797, 799, 801, 803-806, 808, 809, 811-814, 818, 820-822, 825-827, 831-834, 836, 837, 839, 840, 841, 843-845, 848, 849, 851-855, 857, 858, 860-862, 865-869, 872-874, 876-881, 884-886, 889, 893, 894, 900-903, 907-922, 924, 927-930, 932, 934, 938-941, 943, 944, 946-948, 951, 953, 954, 958-963, 965-967, 970, 972-980, 982, 983, 985, 986, 991-994, 996-1000, 1003-1008, 1010-1013, 1016, 1017, 1019, 1022, 1023, 2007, 2008, 211037, 2008-0068, 555A, & 778A. System Code #882140, Serial # 102, 134, 141, 146, 147, 159, 160, 161, 167, 175, 176, 190, 209, 210, 216, 225, 226, 257, 259, 268-270, 274, 289, 290, 302, 304, 314, 315, 318, 323, 333, 341, 343, 344, 348, 350, 364, 366, 381, 386, 409, 414, 420, 421, 423, 436, 441, 455, 463, 469, 472, 473, 488, 489, 497, 498, 501, 531, 532, 536-539, 565, 566, 578, 588, 589, 591, 596, 598-600, 608, 610, 613, 615, 616, 622, 631, 632, 634, 637, 653, 666, 674, 676-678, 685, 689, 700, 709, 710, 731, 732, 741, 742, 748, 757, 763, 768, 774, 785, 802, 810, 816, 819, 824, 828, 829, 830, 838, 846, 856, 863, 864, 870, 871, 875, 884, 891, 892, 898, 904, 905, 931, 933, 936, 942, 945, 949, 950, 952, 955-957, 964, 968, 981, 989, 990, 995, 1001, 1002, 1009, 1015, 1018, & 1021. System Code #882130/40, Serial #184, 730, 122, 136, 254, 255, 284, 614, 696, 874, 906, & 984. System Code #882140/882130, Serial #113, 148, 152, 178, 179, 187, 188, 217, 238, 243, 247, 248, 278, 288, 345, 367, 371, 373, 380, 384, 389, 397, 397, 399, 408, 413, 415, 435, 439, 439, 440, 453, 477-479, 486, 504, 512, 525, 526, 528, 533, 535, 540, 547, 564, 567, 568, 577, 579, 581, 638, 639, 644, 645, 651, 652, 659, 667, 680, 747, 758, 815, 850, 859, 882, 883, 890, 896, 897, 899, 925, & 969.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, including the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PRO, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and the territory of Puerto Rico; and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Egypt, Finland, France, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Romania, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, & United Kingdom.
  • 제품 설명
    Gamma camera systems: AXIS SPECT Systems & IRIX SPECT Systems, Model #: AXIS- 882130, IRIX- 882140. Philips Healthcare. || Used to do nuclear medicine diagnostic imaging of various body organs.
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc
Device Recall Axis Gamma Camera
  • 모델명 / 제조번호(시리얼번호)
    Model Numbers: 210714, 210880 and 211037 Part Numbers: 4535 665 13461, or N210714 Axis System, 3/8" Crystals 4535 665 16601, or N210880 Axis System 3/4" Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665 13501, or N211039 Axis System 3/4 Precision 4535 679 46301, or N211280 Axis System 3/8 Precision 4535 671 67421, or N211282 Axis System 3/4 Precision (Note: Due to a part number scheme change at the firm, either number is representative of the identified system)
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- USA including states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, and WV, Puerto Rico and countries of Argentinia, Austrailia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Philipines, Poland, Singapore, South Africa, Spain, Switzerland, and United Kingdom.
  • 제품 설명
    Axis Gamma Camera, Scintillation (gamma) camera, Philips Medical System, Cleveland, OH 44143
  • Manufacturer
    Philips Medical Systems (Cleveland) Inc