Device Recall BIPLANE XRay Imaging Systems with Velara Generator

Each unit is identified with a SITE number:  76992, 103526, 103581, 103921, 104020, 104021, 104068, 104386,  104497, 104628, 104926, 104950, 104953, 104959, 105184, 105399, 105581, 105585, 105654, 504655, 504674, 504733, 504742, 504779, 504868, 504921, 505067, 505068, 505120, 505356, 505380, 505530, 505611, 505703, 505903, 506008, 506026, 506069, 506119, 506509, 506655, 519118, 519136, 519196, 519197, 519678, 519730, 519981, 520275, 520582, 520666, 520688, 520756, 520793, 520949, 520964, 521149, 521325, 521525, 522136, 522456, 530396, 530653, 530654, 530660, 531649, 531758, 531799, 531926, 531939, 532152, 532218, 532240, 532241, 532383, 532614, 533288, 533290, 533397, 534131, 534156, 534786, 535345, 535761, 535775, 536028, 536031, 536034, 536035, 536037, 536042, 536171, 536715, 536789, 536899, 537175, 537593, 537631, 537804, 538028, 538095, 538099, 538157, 538172, 538387, 538409, 538514, 538516, 539213, 539326, 539628, 540184, 540237, 540461, 540721, 541237, 541238, 541239, 541276, 541577, 541589, 541590, 542382, 542413, 542557, 542714, 542963, 543289, 543411, 543690, 543879, 543953, 543989, 544306, 544395, 544543, 544635, 544656, 544668, 544844, 545025, 545262, 545396, 545518, 545583, 545604, 545753, 545882, 545884, 545997, 546013, 546119, 546149, 546569, 546906, 547173, 547215, 547431, 547642, 547715, 547769, 547823, 547922, 548005, 548020, 548036, 548082, 548140, 548288, 548383, 548618, 549202, 549242, 549368, 549370, 549903, 550198, 550691, 550758, 550812, 550935, 551855, 552355, 552599, 552639, 552969, 553685, 553699, 553766, 554763, 554802, 554970, 555293, 555299, 555356, 555834, 558604, 558945,  41443586, 41443609, 41443627, 41443647, 41443727, 41443765, 41443804, 41443909, 41444645, 41444647, 41444650, 41444689, 41444752, 41444816, 41445118, 41445432, 41445448, 41445501, 41445538, 41445615, 41445628, 41446230, 41446262, 41446773, 41455885, 41455897, 41455920, 41455925, 41455933, 41455944, 41455953, 41660520, 41780160, 41793290, 41795344, 41796154, 42046093, 42046440, 42057324, 42064058, 42067824, 42394072, 42479274, 42508759, 42553772, 42564341, 42625859, 42735090, 42891020, 42891095, 42891704, 43043666, 43058934, 43164789, 43173591, 43315510, 43436747, 43443622, 43453735, 43635004, 43670742, 43848923, 44028554, 44066424, 44584972, 44616211, 44654768, 44735751, and 44892370.

Radiology Devices

2

No

Nationwide Distribution

BIPLANE X-ray Imaging Systems included Allura XPER FD10/10, FD20/10, FD20/20, Integris BH5000, and Integris Allura 12-15 Biplane. || The BIPLANE system has two C-arms and it allows the operator to image in two planes: Lateral and Frontal. It has a C-arm on the stand and C-arm suspended from the ceiling. || The product's brochure is labeled in part: "Philips Healthcare Global Information Center...P.O. Box 1286...5602 BG Eindhoven...The Netherlands".