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U.S. Department of Health and Human Services

Class 2 Device Recall AXIS SPECT Systems & IRIX SPECT Systems

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 Class 2 Recall
AXIS SPECT Systems & IRIX SPECT Systems
see related information
Date Posted February 10, 2012
Recall Status1 Terminated on February 22, 2013
Recall Number Z-0988-2012
Recall Event ID 60902
Premarket Notification
510(K) Number
K964712 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product 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.
Code Information 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.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
Philips was informed that the detector buckets may experience weakness over time. As a result, this could cause the detector bucket to separate from the mounting plate of the gantry and eventually result in the detector falling.
FDA Determined
Cause 2
DESIGN: Process Design
Action On 11/15/2011 Philips sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected product, the problem, the hazard involved, and the actions to be taken by users and the Philips. Customers are to place the letter in their User Documentation. Philips service will arrange a time to inspect customers' systems and conduct the appropriate field safety correction. Customers are to contact their local Philips representative if they need further support or information. In the US and Canada, customers can contact Philips Healthcare Customer Care Solutions Center at 1-800-722-9377.
Quantity in Commerce 795 units
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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