Class 2 Device Recall Integris BH5000

• Date Initiated by Firm: October 23, 2008
• Date Posted: September 22, 2010
• Recall Status: Terminated on August 10, 2011
• Recall Number: Z-2473-2010
• Recall Event ID: 50114
• 510(K)Number: K984545
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Philips Integris BH5000 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: 103581, 105399, 104386, 105184, 105585, 104021, 105581, 505120, 104020, 504733, 505067, 104068, 504868, 504921, 504674, 505068, 504903, 104628, 105654, 505530, 505703, 505380, 504655, 104926, 504779, 506026, 505611, 506069, 506119, 504742, 104497, 506008, 505903, 506655, 103921, 531926, 519136, 505356, 104950, 519118, 103526, 104953, 104953, 519730, 520949, 520275, 104959, 76992, 520582, 519981, 521525, 519196, 521325, 521149, 522456, 506509, 520688, 44147585, 530653, 531939, 530654, 522136, 520666, 530660, 520964, 532383, 531649, 531799, 532218, 532152, 520756, 533290, 532240, 530396, 532241, 534131, 531758, 534786, 535761, 535775, 519197, 548140, 537175, 533288, 535345, 537593, 538172, and 534156.
• 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: 88 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, INC.