Class 2 Device Recall BV Pulsera R2.2 Mobile Xray system

• Date Initiated by Firm: September 05, 2008
• Date Posted: October 25, 2010
• Recall Status: Terminated on December 07, 2010
• Recall Number: Z-0140-2011
• Recall Event ID: 49605
• 510(K)Number: K010435
• Product Classification: Mobile X-ray system - Product Code JAA
• Product: Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on the front lower right side of the module or under the stand cover. The device's brochure is labeled in part: "Philips...Mobile C-Arm systems BV Pulsera".
• Code Information: 1331 units are identified with Site numbers: 541547, 541556, 541557, 541558, 542423, 542426, 542427, 542584, 542684, 542769, 542854, 543059, 543219, 543220, 543222, 543458, 543459, 543460, 543461, 543462, 543463, 543464, 543465, 543561, 543562, 543616, 543828, 543862, 543947, 544191, 544301, 544367, 544396, 544411, 544456, 544457, 544458, 544459, 544460, 544461, 544462, 544463, 544464, 544465, 544466, 544467, 544469, 544470, 544471, 544473, 544474, 544475, 544476, 544533, 544562, 544603, 544622, 544905, 544925, 544926, 544972, 544984, 545032, 545039, 545085, 545102, 545103, 545136, 545139, 545140, 545284, 545397, 545492, 545631, 545751, 545822, 545922, 545924, 545961, 545996, 546026, 546086, 546145, 546461, 546508, 546516, 546531, 546579, 546580, 546680, 546687, 546786, 546788, 546790, 546791, 546851, 546999, 547000, 547082, 547169, 547171, 547172, 547199, 547221, 547284, 547288, 547298, 547299, 547349, 547350, 547351, 547352, 547375, 547602, 547603, 547604, 547605, 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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: Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor
• FDA Determined Cause: Component design/selection
• Action: On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions.
• Quantity in Commerce: 1331 units
• Distribution: Nationwide 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 = JAA and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.