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U.S. Department of Health and Human Services

Class 2 Device Recall Philips BV Endura

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  Class 2 Device Recall Philips BV Endura see related information
Date Initiated by Firm December 14, 2010
Date Posted March 08, 2011
Recall Status1 Terminated 3 on February 28, 2012
Recall Number Z-1604-2011
Recall Event ID 57611
510(K)Number K010435  
Product Classification Mobile X-Ray System - Product Code IXL
Product Philips BV Endura, Rel. 2, 718074.

Mobile C-Arm X-Ray systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications.
Code Information Site Numbers: 548686, 556612, 41416327, 41446303, 41566246, 41585083, 43896129, 45592395, 47198056, and 49736876.  
Recalling Firm/
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 Ext. 5
Manufacturer Reason
for Recall
The fixing strap of the belt holding the CBX Laser to the Image Intensifier may be detached during a procedure when used with the BV Libra and the BV Pulsera/Endura Systems.
FDA Determined
Cause 2
Device Design
Action On 01/06/11, Philips sent an URGENT Device Correction Notice, dated 01/05/2011, to their consignees. The consignees were informed that the fixing strap of the Laser Aiming Device Image Intensifier may inadvertently detach when used with BV Libra, BV Endura Rel. 2, and BV Pulsera Rel 2.3 Mobile X-Ray systems. Specifically the draw latch of the fixing strap holding the CBX Laser to the Image Intensified can be accidentally released during a procedure when used with the above Mobile X-Ray systems. While waiting for Philips to implement their corrective action, the consignees are advised to fix the closed latch body of the draw latch to the metal band using a Tie Wrap. Without securing the latch with a Tie Wrap, the device should not be used. The consignees can contact Philips Call Center at 1-800-722-9377, select 5, and reference FCO 71800035 with any questions about this recall.
Quantity in Commerce 10 units
Distribution Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Washington, DC.
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 = IXL and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.