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U.S. Department of Health and Human Services

Class 2 Device Recall ALLURA XPER FD10/10

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  Class 2 Device Recall ALLURA XPER FD10/10 see related information
Date Initiated by Firm May 26, 2009
Date Posted December 07, 2010
Recall Status1 Terminated 3 on December 09, 2010
Recall Number Z-0547-2011
Recall Event ID 57069
Product Classification System, x-ray, angiographic - Product Code IZI
Product ALLURA XPER FD10/10
The intended uses of the Allura XPER X-ray systems involved with this report are angiographic X-ray systems with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures.
Code Information Site numbers: 41660520, 43043666, 43164789, 43848923, 44028554, and 105082.   
Recalling Firm/
Philips Medical Systems North America Co. Phillips
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Healthcare Call Center
Manufacturer Reason
for Recall
The Printed Circuit Board (PCB) in the Main-cabinet. Further investigation revealed that a manufacturing error in the PCB is responsible for the reliability issue. As a result, the complete system may shut down and not re-start.
FDA Determined
Cause 2
Action Philips began mailing out an URGENT-Device Correction letter on May 26, 2009. Philips sent out a second URGENT-Device Correction letter dated June 4, 2009, to all consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to contact their local Philips representative immediately if their system completely shut down and would not restart. A mandatory Field Change Order 72200144 was issued for replacement of the Printed Circuit Board (PCB) in the Allura XPER FD system. A mandatory Field Change Order FCO 70800091 was issued for replacement of the Printed Circuit Board (PCB) in the MultiDiagnost Eleva with FD system. The consignees were to be contacted by their Philips Representative for implementation of the corrective action. The firm's Field Engineer would replace the power tray of the systems. If the consignees needed any further information or support concerning this issue, they were to contact the call Center at 800-722-9377, # 5 and reference FCO 72200144 or FCO 70800091 with any questions.
Quantity in Commerce 6 units
Distribution Nationwide Distribution including the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, and WI.
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.