Class 2 Device Recall Integris Allura Flat Detector 9C

• Date Initiated by Firm: October 23, 2008
• Date Posted: September 22, 2010
• Recall Status: Terminated on August 10, 2011
• Recall Number: Z-2477-2010
• Recall Event ID: 50114
• 510(K)Number: K022899
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Philips Integris Allura Flat Detector 9C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 PRODUCTS 6501 * (number located on the generator cabinet).; Intended use for Angiographic X-ray system with and without a solid state X-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
• Code Information: Devices are identified with Site Numbers: 105191, 103128, 104514, 530390, 103780, 105082, 103781, 102948, 104890, 522293, 105615, 504493, 105186, 105656, 504659, 504792, 103561, 103331, 505106, 105140, 505107, 505486, 504789, 104642, 104075, 104515, 105947, 506169, 522250, 505707, 504913, 505759, 506785, 504915, 530662, 504916, 505809, 504872, 519576, 532246, 105157, 520430, 105912, 519198, 504797, 504798, 504806, 105598, 504807, 506230, 104149, 506232, 105784, 506616, 506564, 105390, 506403, 532215, 104501, 521223, 504730, 531837, 105081, 531813, 500042, 532292, 105779, 103265, 536425, 105946, 104464, 519576, 532534, 105940, 520004, 102560, 504750, 500029, 500028, 532446, 531805, 532445, 105674, 105960, 532535, 504666, 521892, 504665, 522162, 520956, 500038, 522440, 532612, 519901, 531806, 522177, 521769, 521770, 532652, 522135, 533343, 522119, 522118, 520882, 505281, 533236, 504770, 521854, 533401, 532986, 520761, 105136, 533418, 530361, 534233, 505572, 531753, 531651, 522446, 505668, 533796, 505587, 505651, 504747, 533286, 505538, 505876, 533922, 505805, 533861, 534221, 505254, 536090, 505679, 535728, 504940, 505719, 533085, 506148, 534251, 506170, 105655, 534813, 506049, 534440, 506047, 534218, 506657, 534477, 534478, 505860, 534479, 505861, 534476, 505925, 532615, 506408, 532616, 532617, 506637, 532613, 521537, 521545, 506370, 534717, 505989, 530669, 521463, 534743, 534758, 534237, 520431, 534876, 103564, 534874, 519541, 520524, 520523, 535614, 506621, 519535, 506178, 519534, 104956, 540841, 104958, 534681, 104955, 104957, 104952, 534630, 104954, 506658, 103562, 535224, 519533, 535400, 506322, 533967, 535250, 506654, 535342, 521853, 104925, 534160, 519594, 506476, 519537, 519548, 530460, 534268, 520525, 530463, 519677, 519771, 538763, 536379, 519115, 536639, 520236, 519812, 520481, 519213, 520309, 104670, 537020, 519214, 519680, 519733, 536777, 519738, 537644, 520809, 506538, 535979, 521650, 537065, 519899, 534427, 521320, 520681, 506397, 522065, 533619, 520680, 521711, 519211, 521318, 520251, 530459, 538269, 539099, 521661, 521763, 522245, 522243, 530370, 521802, 522247, 522458, 522038, 522418, 522191, 521131, 530421, 532074, 520793, 532178, and 532080.
• Recalling Firm/ Manufacturer: Philips Medical Systems North America Co. Phillips; 22100 Bothell Everett Hwy; Bothell WA 98021-8431
• For Additional Information Contact: Philips Call Center; 800-722-9377
• Manufacturer Reason for Recall: A high voltage reliability issue resulting in the loss of the x-ray generation and this can cause an intermittent stop of fluoro acquisition and exposure during an examination without warning and hence no image on the display.
• FDA Determined Cause: Other
• Action: The firm, Philips, sent "URGENT-Device Correction" letters dated November 10, 2008, to their customers and informed them about the reliability issue in the Allura XPER and Integris X-ray systems with the High Voltage Velera (HV) Generator. This reliability issue can lead to a system error causing intermittent loss of fluro and/or exposure acquisition, potentially resulting in the loss of the X-ray image on the display. The customers are advised if they experience High Voltage Generator reliability issue and the HV Generator stops working generating an O3EA error, a cold restart is required and reboot the system when the X-Ray image disappears. The firm will implement multiple mandatory Field Change Orders (FCOs) to solve the Generator reliability by updating the software for each X-ray system. The customers could contact Philips Care Center at 800-722-9377, #5, #4, #1 for any questions regarding this recall or 425-487-7469.
• Quantity in Commerce: 269 units in US
• Distribution: Worldwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = IZI and Original Applicant = PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.