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U.S. Department of Health and Human Services

Class 2 Device Recall Computed Tomography XRay System, Extended Brilliance Workspace ( EBW)

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 Class 2 Recall
Computed Tomography XRay System, Extended Brilliance Workspace ( EBW)
see related information
Date Posted December 21, 2012
Recall Status1 Terminated on December 24, 2013
Recall Number Z-0479-2013
Recall Event ID 63394
Premarket Notification
510(K) Number
K961464 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information Model #728260, Serial #s, 12876, 13924, 13994, 13996, 14104, 14116, 14677, 14682, 14694, 14695, 14702, 14707, 14710, 14727, 14728, 14730, 14824, 14840, 14926, 14930, 14932, 14940, 15008, 15015, 15017, 15023, 15036, 15081, 15085, 15146, 15329, 15354, 15393, 15397, 15398, 15399, 15400, 15401, 15402, 15403, 15451, 15453, 15550, 15551, 15552, 15553, 15554, 15555, 15556, 15557, 15558, 15559, 15560, 15561, 15562, 15563, 15564, 15565, 15566, 15567, 15568, 15569, 15570, 15571, 15572, 15573, 15574, 15575, 15576, 15577, 15578, 15579, 15580, 15581, 15582, 15583, 15584, 15585, 15586, 15587, 15588, 15589, 15590, 15591, 15592, 15593, 15594, 15595, 15596, 15597, 15598, 15599, 15600, 15601, 15602, 15603, 15604, 15605, 15606, 15607, 15608, 15609, 15610, 15611, 15612, 15613, 15614, 15615, 15616, 15617, 15618, 15619, 15620, 15621, 15622, 15623, 15624, 15625, 15626, 15627, 15628, 15629, 15630, 15631, 15632, 15633, 15634, 15635, 15636, 15637, 15638, 15639, 15640, 15641, 15642, 15643, 15644, 15645, 15646, 15647, 15648, 15649, 15650, 15651, 15652, 15653, 15654, 15655, 15656, 15657, 15658, 15659, 15660, 15661, 15662, 15663, 15664, 15665, 15666, 15667, 15668, 15669, 15670, 15671, 15672, 15673, 15674, 15675, 15676, 15677, 15678, 15679, 15680, 15681, 15682, 15683, 15684, 15685, 15686, 15687, 15689, 15690, 15691, 15692, 15694, 15695, 15696, 15697, 15698, 15699, 15700, 15701, 15702, 15703, 15704, 15705, 15706, 15707, 15708, 15709, 15710, 15711, 15712, 15713, 15714, 15715, 15716, 15717, 15718, 15719, 15720, 15721, 15722, 15723, 15724, 15725, 15726, 15727, 15728, 15729, 15730, 15731, 15732, 15734, 15735, 15736, 15737, 15753, 15754, 15755, 15756, 15757, 15758, 15760, 15761, 15762, 15763, 15764, 15765, 15766, 15767, 15768, 15770, 15771, 15772, 15800, 15801, 15802, 15803, 15804, 15805, 15806, 15807, 15808, 15809, 15810, 15811, 15812, 15813, 15814, 15818, 15820, 15821, 15826, 15827, 15828, 15829, 15830, 15831, 15832, 15834, 15835 & 15900.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Kumundini J. Carter
440-483-3032
Manufacturer Reason
for Recall
Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW.
FDA Determined
Cause 2
DESIGN: Software Design (Manufacturing Process)
Action Philips sent a Urgent Medical Device Correction letter dated September 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Philips is issuing a system update to all of the Extended Brilliance Workspace (EBW) systems currently running software version 4.5.4. The update will provide a number of improvements to the overall quality and functionality of the EBW systems. If you need further information or support concerning this issue, please contact your local Philips representative. In the United States and Canada, please call the Philips Healthcare Customer Care Solutions Center at 1-800-722-9377, and follow the recorded menu options to reach a Customer Solutions Engineer; in all other countries please dial your local Philips Healthcare office.
Quantity in Commerce 265 units
Distribution Worldwide Distribution--US (nationwide) including the states of AR, OH, OR, PA, TX VA & WI., and the countries of Algeria, Australia, Brazil, China, Ecuador, Finland, France, Germany, Hong Kong, India, Italy, Lebanon, Libyan Arab Jamahiriya, Russia, South Korea & United Kingdom
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = ELSCINT, INC.
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