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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall BV Pulsera R2.2 Mobile Xray system see related information
Date Initiated by Firm September 05, 2008
Date Posting Updated October 25, 2010
Recall Status1 Terminated 3 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 558387, 558388, 558389, 558390, 558391, 558392, 558393, 558394, 558395, 558418, 558419, 558423, 558424, 558425, 558426, 558427, 558440, 558441, 558442, 558444, 558452, 558453, 558455, 558500, 558522, 558523, 558531, 558567, 558569, 558611, 558632, 558633, 558634, 558635, 558638, 558647, 558654, 558693, 558697, 558698, 558699, 558790, 558835, 558843, 558844, 558847, 558861, 558862, 558867, 558920, 558922, 558924, 558925, 558966, 558967, 559003, 559009, 559026, 559045, 559068, 559101, 559251, 559254, 559294, 559319, 559322, 559330, 559331, 559363, 559364, 559415, 559417, 559423, 559435, 559448, 559495, 559533, 559537, 559563, 559584, 559655, 559658, 559679, 559690, 559775, 559877, 559880, 559924, 559963, 41416302, 41416329, 41443563, 41443566, 41443590, 41443601, 41443603, 41443605, 41443611, 41443616, 41443668, 41443673, 41443675, 41443721, 41443746, 41443748, 41443764, 41443831, 41443872, 41444449, 41444577, 41444618, 41444630, 41445304, 41445356, 41445415, 41445423, 41445436, 41445441, 41445453, 41445472, 41445476, 41445484, 41445487, 41445504, 41445506, 41445509, 41445521, 41445528, 41445534, 41445553, 41445599, 41445657, 41445717, 41445718, 41445728, 41445740, 41445741, 41445775, 41445791, 41445794, 41445802, 41445815, 41445894, 41445895, 41445911, 41445915, 41445921, 41445922, 41445933, 41446005, 41446009, 41446040, 41446060, 41446086, 41446088, 41446095, 41446183, 41446185, 41446186, 41446243, 41446264, 41446272, 41446285, 41446310, 41446338, 41446396, 41446424, 41446449, 41446454, 41446667, 41446770, 41446789, 41455878, 41481071, 41481139, 41481150, 41490306, 41490307, 41490308, 41490309, 41490311, 41490312, 41490314, 41490315, 41490316, 41490318, 41555898, 41556812, 41566245, 41566346, 41576092, 41577033, 41577782, 41585081, 41585198, 41587498, 41611719, 41611720, 41616194, 41616195, 41620935, 41620966, 41620994, 41621991, 41622664, 41630466, 41630529, 41630534, 41630562, 41630795, 41632199, 41632201, 41645797, 41647329, 41657683, 41658375, 41658562, 41658563, 41658564, 41658565, 41701158, 41701180, 41701188, 41710489, 41711608, 41712352, 41712375, 41713383, 41725527, 41725782, 41726634, 41727262, 41748088, 41748089, 41750289, 41750637, 41757081, 41757083, 41757225, 41757995, 41757996, 41765919, 41765927, 41767945, 41768050, 41768058, 41768059, 41780151, 41780384, 41781325, 41781354, 41781423, 41783430, 41783605, 41783704, 41792689, 41793821, 41793882, 41794417, 41795593, 41796073, 41796150, 41796152, 41832433, 41833197, 41833714, 41884073, 41885442, 41885443, 41898013, 41936644, 41938193, 41938323, 41939336, 41953816, 41953942, 41957602, 41980506, 41980509, 41986345, 41986348, 41986353, 41986793, 41987067, 41987951, 41997886, 42000523, 42028669, 42029464, 42037365, 42053457, 42054978, 42056714, 42057341, 42084783, 42122302, 42122304, 42182071, 42182116, 42182122, 42182142, 42182150, 42182154, 42182158, 42229074, 42250965, 42250966, 42441055, 42442866, 42455439, 42485796, 42564749, 42573198, 42608333, 42683563, 42917165, 43128864, 43164321, 43171778, 43171779, 43198691, 43207053, 43209156, 43209392, 43350703, 43525480, 43569447, 43592314, 43681994, 43689105, 43706191, 44354078, 44644242, 44908585, 45378574, 49062534, and 49336814.
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 2
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.
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