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U.S. Department of Health and Human Services

Class 2 Device Recall Allura XPER FD20/10

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  Class 2 Device Recall Allura XPER FD20/10 see related information
Date Initiated by Firm October 23, 2008
Date Posted September 22, 2010
Recall Status1 Terminated 3 on August 10, 2011
Recall Number Z-2475-2010
Recall Event ID 50114
510(K)Number K984545  K033737  
Product Classification System, x-ray, angiographic - Product Code IZI
Product Philips Allura XPER FD 20/10 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:  538095, 538099, 540721, 542382, 539213, 544844, 542963, 544306, 544543, 545518, 543953, 545262, 545583, 544635, 546119, 546906, 547431, 546149, 547914, 547642, 548383, 548005, 540461, 544656, 547215, 547715, 545882, 550812, 550758, 550198, 549202, 550691, 553766, 548618, 552639, 543690, 548036, 548020, 544668, 550935, 548082, 549370, 553685, 552355, 41455933, 553699, 552599, 558604, 41444689, 549242, 41443586, 41443727, 41443765, 41443909, 41444645, 41444752, 41444816, 41455925, 41455953, and 42046093.
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 2		 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 60 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.
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