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.
This recall has been terminated (originally issued December 21, 2012).
- Recall Initiated
- September 28, 2012
- Posted
- December 21, 2012
- Terminated
- December 24, 2013
- Recall Number
- Z-0479-2013
- Quantity
- 265 units
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
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
Lot / Code Info
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.
Root Cause
Software design
Action Taken
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.