Class 2 Device Recall Integris H5000F

• Date Initiated by Firm: October 23, 2008
• Date Posted: September 22, 2010
• Recall Status: Terminated on August 10, 2011
• Recall Number: Z-2472-2010
• Recall Event ID: 50114
• 510(K)Number: K984545
• Product Classification: System, x-ray, angiographic - Product Code IZI
• Product: Philips Integris H5000F 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: 504904, 102923, 104060, 104927, 103751, 535012, 105411, 103729, 104139, 105156, 500052, 105917, 105950, 105582, 104512, 103275, 102730, 101952, 504988, 105583, 505064, 105866, 504977, 504871, 105153, 536796, 105631, 105100, 505453, 105951, 103696, 105386, 504646, 504920, 500004, 105952, 105961, 504769, 505135, 504795, 103289, 505546, 105908, 504908, 105139, 505008, 534041, 105343, 505271, 505680, 505363, 105742, 104536, 504733, 505270, 505520, 505111, 519179, 505650, 504776, 103927, 505252, 505804, 505706, 506048, 506121, 540048, 105953, 506222, 538538, 105409, 506060, 506369, 505886, 506225, 519673, 504636, 506009, 104106, 535091, 504638, 506693, 531926, 505803, 519199, 538194, 505017, 539094, 506778, 505424, 505250, 104668, 520840, 103525, 520189, 104859, 519676, 505807, 519767, 102564, 506469, 520526, 520147, 520517, 500041, 519874, 506541, 506462, 521918, 537466, 519536, 519212, 521562, 504344, 521310, 530464, 105073, 530466, 521224, 505421, 522224, 105304, 105137, 519868, 530656, 521313, 530658, 105684, 530668, 534627, 530655, 532148, 532653, 533567, 532234, 533541, 534159, 532172, 533397, 532241, 534252, 535777, 533394, 535387, 538537, 537731, 535348, 540468, 534879, and 534155.
• 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: 150 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