Class 2 Device Recall Integris XPER FD10 F/C

• Date Initiated by Firm: October 23, 2008
• Date Posted: September 22, 2010
• Recall Status: Terminated on August 10, 2011
• Recall Number: Z-2474-2010
• Recall Event ID: 50114
• 510(K)Number: K022899
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Philips Integris XPER FD10 F/C Angiographic X-ray system. This system with Velara Generator can be identified as type number 9890 000 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: 41416358, 554019, 43067304, 555206, 550172, 42393465, 554791, 554768, 553234, 41446290, 556783, 41903960, 554550, 544051, 544048, 556311, 41443882, 38377, 554631, 14147, 41445645, 548067, 41444662, 41446080, 41446144, 557512, 553925, 41443581, 41455906, 552586, 41446807, 554427, 556708, 105686, 104497, 104950, 532446, 104953, 530653, 531926, 533397, 504747, 543989, 534478, 535400, 536379, 537065, 520793, 103281, 556053, 41455894, 554804, 557385, 41445235, 41445816, 530667, 530393, 530666, 534731, 532800, 532799, 535416, 531942, 533762, 535667, 535415, 536138, 534634, 536721, 533283, 533282, 533278, 534638, 537698, 536966, 538744, 534678, 538486, 538485, 538476, 537630, 538368, 540016, 539107, 538903, 540841, 540234, 540301, 537745, 540488, 539595, 540269, 103283, 542113, 542117, 539455, 540070, 539641, 540235, 541822, 535769, 547321, 541409, 541592, 541029, 541026, 534941, 547660, 540386, 539480, 543194, 543209, 537855, 538084, 534928, 541597, 540311, 543702, 543198, 543433, 533289, 543108, 544145, 535212, 543873, 538432, 544506, 541588, 544572, 543829, 532226, 543610, 541667, 545037, 545069, 545357, 545365, 545296, 545443, 544990, 544992, 545052, 544610, 545966, 546012, 537588, 541510, 544637, 103147, 546934, 543999, 544122, 520275, 547279, 543988, 546572, 547165, 547908, 548147, 537937, 537935, 537589, 548038, 547878, 549451, 545942, 548525, 545395, 548603, 548645, 547159, 548966, 549013, 539516, 532235, 545023, 547600, 547406, 539224, 549400, 547965, 547749, 549792, 551379, 538416, 550255, 547761, 547763, 547762, 551633, 544600, 541080, 532611, 80327, 554896, 555605, 554499, 546560, 546561, 550360, 553137, 41455880, 550124, 41445229, 41455932, and 556773.
• 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: 206 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.