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U.S. Department of Health and Human Services

Class 2 Device Recall Ultraview SL 2200

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  Class 2 Device Recall Ultraview SL 2200 see related information
Date Initiated by Firm November 06, 2009
Date Posted January 19, 2010
Recall Status1 Terminated 3 on July 21, 2011
Recall Number Z-0647-2010
Recall Event ID 53779
510(K)Number K972282  
Product Classification Medical Cathode-Ray Tube Display - Product Code DXJ
Product Spacelabs Model 91367 SL 2200 Compact Monitor

Spacelabs Medical patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products.
Code Information S/N, U.S. Domestic units: 1367-000395, 1367-000396, 1367-000397, 1367-000628, 1367-000629, 1367-000630, 1367-000631, 1367-000632, 1367-000633, 1367-000522, 1367-000525, 1367-000526, 1367-000527, 1367-000601, 1367-000602, 1367-000603, 1367-000604, 1367-000605, 1367-000606, 1367-000477, 1367-000731, 1367-000732, 1367-000733, 1367-000734, 1367-000444, 1367-000831, 1367-000832, 1367-000833, 1367-000437, 1367-000438, 1367-000272, 1367-000454, 1367-000482, 1367-000483, 1367-000433, 1367-000434, 1367-000435, 1367-000436, 1367-000479, 1367-000480, 1367-000481, 1367-000524, 1367-000399, 1367-000400, 1367-000411, 1367-000412, 1367-000735, 1367-000736, 1367-000737, 1367-000738, 1367-000739, 1367-000740, 1367-000741, 1367-000742, 1367-000743, 1367-000744, 1367-000745, 1367-000746, 1367-000747, 1367-000748, 1367-000749, 1367-000439, 1367-000440, 1367-000441, 1367-000442, 1367-000443, 1367-000523, 1367-000530, 1367-000531, 1367-000532, 1367-000663, 1367-000664, 1367-000665, 1367-000691, 1367-000692, 1367-000693, 1367-000694, 1367-000695, 1367-000696, 1367-000697, 1367-000698, 1367-000699, 1367-000700, 1367-000701, 1367-000702, 1367-000703, 1367-000704, 1367-000705, 1367-000706, 1367-000707, 1367-000708, 1367-000709, 1367-000710, 1367-000711, 1367-000712, 1367-000713, 1367-000714, 1367-000715, 1367-000716, 1367-000717, 1367-000718, 1367-000719, 1367-000720, 1367-000528, 1367-000529, 1367-000486, 1367-000487, 1367-000635, 1367-000636, 1367-000637, 1367-000638, 1367-000639, 1367-000640, 1367-000641, 1367-000642, 1367-000643, 1367-000650, 1367-000651, 1367-000652, 1367-000653, 1367-000654, 1367-000655, 1367-000656, 1367-000657, 1367-000658, 1367-000659, 1367-000660, 1367-000661, 1367-000662, 1367-000398, 1367-000644, 1367-000645, 1367-000646, 1367-000647, 1367-000648, 1367-000649, 1367-000777, 1367-000834, 1367-000835, 1367-000836, 1367-000837, 1367-000838, 1367-000839, 1367-000427, 1367-000428, 1367-000429, 1367-000430, 1367-000431, 1367-000432, 1367-000721, 1367-000722, 1367-000723, 1367-000724, 1367-000725, 1367-000726, 1367-000727, 1367-000728, 1367-000729, 1367-000730, 1367-000445, 1367-000519, 1367-000582, 1367-000583, 1367-000584, 1367-000585, 1367-000586, 1367-000587, 1367-000588, 1367-000589, 1367-000590, 1367-000591, 1367-000592, 1367-000593, 1367-000666, 1367-000667, 1367-000668, 1367-000669, 1367-000670, 1367-000776, 1367-000779, 1367-000780, 1367-000781, 1367-000782, 1367-000783, 1367-000784, 1367-000785, 1367-000786, 1367-000787, 1367-000788, 1367-000789, 1367-000790, 1367-000791, 1367-000792, 1367-000793, 1367-000794, 1367-000795, 1367-000796, 1367-000797, 1367-000798, 1367-000799, 1367-000800, 1367-000801, 1367-000802, 1367-000803, 1367-000804, 1367-000805, 1367-000806, 1367-000807, 1367-000808, 1367-000809, 1367-000810, 1367-000811, 1367-000812, 1367-000813, 1367-000814, 1367-000815, 1367-000816, 1367-000817, 1367-000818, 1367-000819, 1367-000820, 1367-000821, 1367-000822, 1367-000823, 1367-000824, 1367-000825, 1367-000826, 1367-000827, 1367-000828, 1367-000829, 1367-000830, 1367-000571, 1367-000572, 1367-000573, 1367-000574, 1367-000575, 1367-000576, 1367-000577, 1367-000578, 1367-000579, 1367-000580, 1367-000581, 1367-000609, 1367-000610, 1367-000611, 1367-000612, 1367-000613, 1367-000614, 1367-000615, 1367-000616, 1367-000617, 1367-000618, 1367-000619, 1367-000620, 1367-000621, 1367-000622, 1367-000623, 1367-000624, 1367-000625, 1367-000626, 1367-000627, 1367-000520, 1367-000750, 1367-000751, 1367-000752, 1367-000753, 1367-000754, 1367-000755, 1367-000756, 1367-000757, 1367-000758, 1367-000759, 1367-000760, 1367-000761, 1367-000762, 1367-000763, 1367-000764, 1367-000765, 1367-000243, 1367-000671, 1367-000672, 1367-000673, 1367-000674, 1367-000675, 1367-000676, 1367-000677, 1367-000678, 1367-000679, 1367-000680, 1367-000681, 1367-000682, 1367-000684, 1367-000685, 1367-000686, 1367-000687, 1367-000688, 1367-000689, 1367-000690, 1367-000607, 1367-000608, 1367-000771, 1367-000772, 1367-000774, 1367-000775, 1367-000450, 1367-000451, 1367-000452, 1367-000453.  Foreign units:, 1367-000447, 1367-000448, 1367-000449, 1367-000484, 1367-000488, 1367-000251, 1367-000413, 1367-000414, 1367-000415, 1367-000446, 1367-000455, 1367-000456, 1367-000457, 1367-000458, 1367-000459, 1367-000460, 1367-000461, 1367-000462, 1367-000463, 1367-000464, 1367-000465, 1367-000466, 1367-000467, 1367-000468, 1367-000469, 1367-000470, 1367-000471, 1367-000472, 1367-000473, 1367-000474, 1367-000475, 1367-000476, 1367-000478, 1367-000485, 1367-000489, 1367-000490, 1367-000491, 1367-000492, 1367-000493, 1367-000494, 1367-000495, 1367-000496, 1367-000497, 1367-000498, 1367-000499, 1367-000500, 1367-000501, 1367-000502, 1367-000503, 1367-000504, 1367-000505, 1367-000506, 1367-000507, 1367-000508, 1367-000509, 1367-000510, 1367-000511, 1367-000512, 1367-000513, 1367-000514, 1367-000515, 1367-000516, 1367-000517, 1367-000518, 1367-000521, 1367-000533, 1367-000534, 1367-000535, 1367-000536, 1367-000537, 1367-000538, 1367-000539, 1367-000540, 1367-000541, 1367-000542, 1367-000543, 1367-000544, 1367-000545, 1367-000546, 1367-000547, 1367-000548, 1367-000549, 1367-000550, 1367-000551, 1367-000552, 1367-000553, 1367-000554, 1367-000555, 1367-000556, 1367-000557, 1367-000558, 1367-000559, 1367-000560, 1367-000561, 1367-000562, 1367-000563, 1367-000564, 1367-000565, 1367-000566, 1367-000567, 1367-000568, 1367-000569, 1367-000570, 1367-000595, 1367-000596, 1367-000597, 1367-000598, 1367-000599, 1367-000600, 1367-000634, 1367-000683, 1367-000769, 1367-000770, and 1367-000773.  
Recalling Firm/
Manufacturer		 Spacelabs Healthcare, Incorporated
5150 220th Ave Se
Issaquah WA 98029-6834
For Additional Information Contact Al Van Houdt
425-657-7200 Ext. 5970
Manufacturer Reason
for Recall		 Potential for monitor to shut down and not being able to power on again.
FDA Determined
Cause 2		 Component design/selection
Action On 11/6/09 the firm sent Urgent - Device Correction notifications to customers by certified mail informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. On 11/13/2009 the firm's Global Tech Support sent notification via email to all foreign subsidiaries and distributors informing them of the monitor failure and that a field service engineer will contact the customer to fix the affected device at no cost. Questions are to be directed to Spacelabs Medical's Technical Support at 1-800-522-7025, and 1-425-657-7200 x5089 for those customers outside of the US.
Quantity in Commerce 422 units
Distribution Worldwide 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 = DXJ and Original Applicant = SPACELABS MEDICAL, INC.
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