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U.S. Department of Health and Human Services

Class 2 Device Recall BV Pulsera Rel 2

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  Class 2 Device Recall BV Pulsera Rel 2 see related information
Date Initiated by Firm September 10, 2008
Date Posted September 22, 2010
Recall Status1 Terminated 3 on January 07, 2011
Recall Number Z-2463-2010
Recall Event ID 50066
510(K)Number K010435  
Product Classification System, x-ray, fluoroscopic, image-intensified - Product Code JAA
Product Philips BV Pulsera Mobile X-Ray system with the extended rotation option.
Code Information Devices are identified with Site Numbers:  505029, 506745, 522087, 533824, 536622, 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543862, 543947, 544191, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544622, 544972, 544984, 545085, 545102, 545103, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546680, 546687, 546786, 546788, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547221, 547284, 547288, 547299, 547375, 547602, 547603, 547643, 547656, 547684, 547710, 547746, 547790, 547791, 547805, 547839, 547975, 548004, 548104, 548308, 548354, 548366, 548385, 548397, 548398, 548569, 548602, 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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		 The C-arm rotation brake does not always function properly, and may not hold the C-arm position if the C-arm is not positioned in its maximum rotation and if it is accidentally bumped by medical staff or patients. Unwanted C-arm movement may cause the C-arm to collide with a patient. The brakes function properly if the C-arm is rotated to its maximum positions.
FDA Determined
Cause 2		 Other
Action Philips Medical Systems issued an Urgent Product Correction letter dated September 30, 2008 to consignees. The letter identified the affected device, what the problem is and under what circumstances it can occur, and the actions that should be taken by the customer or user in order to prevent risks for patients or users. Philips will contacdt customers to implement Field Corrective Action (FCO) #71800026), which describes a mechanical brake modification which will be installed by Philips. Until the Field Corrective Action has been completed, users should ensure that the C-arm is placed in the maximum extended position, or ensure that the C-arm is not touched during critical procedures if the C-arm is not in a maximum position. The Philips Call Center can be contacted at 800-722-9377
Quantity in Commerce 1349 units
Distribution Nationwide Distribution: Throughout the US.
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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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