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.
This recall has been terminated (originally issued January 19, 2010).
- Recall Initiated
- November 6, 2009
- Posted
- January 19, 2010
- Terminated
- July 21, 2011
- Recall Number
- Z-0647-2010
- Quantity
- 422 units
- Firm Location
- Issaquah, WA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for monitor to shut down and not being able to power on again.
Distribution
Worldwide Distribution
Lot / Code Info
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.
Root Cause
Component design/selection
Action Taken
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.