FDA Medical Device Recalls (openFDA)
Spacelabs Healthcare, Incorporated: 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.
- Recall number
- Z-0647-2010
- Recalling firm
- Spacelabs Healthcare, Incorporated
- 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.
- Status
- Terminated
- Initiated
- 2009-11-06
- Posted
- 2010-01-19
- Terminated
- 2011-07-21
- Reason
- Potential for monitor to shut down and not being able to power on again.
- Root cause
- 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
- 422 units
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K972282"]
- PMA numbers
- not on file
- Product code
- DXJ
- Firm FEI
- 3010157426
- Firm city
- Issaquah
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28