Spacelabs Healthcare Model 91496 cardiac monitor recalled for inaccurate heart output readings
Certain Spacelabs Healthcare Model 91496 multi-parameter cardiac monitors have a circuit board defect. When the device is in Auto mode, the cardiac output measurement may start too early, causing errors that prevent proper readings or exclude readings that should be included. This could lead to inaccurate patient information and delayed medical decisions.
From the FDA notice · Read the official notice ↗ · All Spacelabs Healthcare recalls
What to do
- Check if your Model 91496 serial number matches the FDA recall list
- Contact Spacelabs Healthcare or your equipment supplier for guidance
- Do not rely solely on Auto mode cardiac output readings until you receive further instruction
- Continue to manually verify readings using alternative methods as appropriate
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
- Sold in
- Nationwide
- Made for
- All ages (under 100 years)
Details
- Units affected
- 1790
- Illnesses reported
- None reported
- Manufactured in
- 35301 Se Center St, Snoqualmie, WA, United States
- Classification
- Class II
- Recall number
- Z-1793-2026
In the FDA's words
- Description
- Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload. Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376, 1496-224400, 1496-224401, 1496-224402, 1496-224403, 1496-224404, 1496-224405, 1496-224406, 1496-223850, 1496-223851, 1496-223852, 1496-224448, 1496-224956, 1496-224957, 1496-224958, 1496-224959, 1496-224960, 1496-224961, 1496-224981, 1496-224258, 1496-223595, 1496-223596, 1496-223597, 1496-223598, 1496-223619, 1496-223620, 1496-223621, 1496-223622, 1496-223623, 1496-223624, 1496-224717, 1496-224718, 1496-223854, 1496-224373, 1496-224374, 1496-223894, 1496-223895, 1496-223896, 1496-223897, 1496-223898, 1496-223899, 1496-223900, 1496-223901, 1496-223902, 1496-223903, 1496-223904, 1496-223905, 1496-223906, 1496-223907, 1496-223918, 1496-225043, 1496-225044, 1496-225045, 1496-225046, 1496-225047, 1496-225048, 1496-225049, 1496-225050, 1496-225051, 1496-225052, 1496-225053, 1496-225054, 1496-225055, 1496-225056, 1496-225057, 1496-225058, 1496-225059, 1496-225060, 1496-225061, 1496-225062, 1496-225063, 1496-225064, 1496-225065, 1496-225066, 1496-225067, 1496-225068, 1496-224949, 1496-223760, 1496-223761, 1496-225154, 1496-224639, 1496-224719, 1496-224720, 1496-224721, 1496-225088, 1496-225089, 1496-224672, 1496-223908, 1496-223909, 1496-223910, 1496-223911, 1496-223912, 1496-223913, 1496-223914, 1496-223915, 1496-223916, 1496-223917, 1496-224637, 1496-224638, 1496-224752, 1496-224744, 1496-224745, 1496-224746, 1496-224747, 1496-224407, 1496-224408, 1496-224409, 1496-224410, 1496-224411, 1496-224412, 1496-224413, 1496-224414, 1496-224415, 1496-224416, 1496-224417, 1496-224418, 1496-224419, 1496-224420, 1496-224421, 1496-224753, 1496-224754, 1496-224755, 1496-224756, 1496-224757, 1496-225129, 1496-223825, 1496-223826, 1496-223829, 1496-223830, 1496-223831, 1496-223832, 1496-223833, 1496-223834, 1496-223835, 1496-223836, 1496-223837, 1496-223838, 1496-223839, 1496-222928, 1496-222929, 1496-223774, 1496-223775, 1496-224063, 1496-224064, 1496-223580, 1496-223618, 1496-223313, 1496-223314, 1496-223315, 1496-223316, 1496-223317, 1496-223318, 1496-223319, 1496-223320, 1496-223321, 1496-223322, 1496-223323, 1496-223325, 1496-223326, 1496-223327, 1496-223328, 1496-223330, 1496-223331, 1496-223332, 1496-223333, 1496-223334, 1496-223335, 1496-223336, 1496-223337, 1496-223338, 1496-223339, 1496-223340, 1496-223341, 1496-223342, 1496-223419, 1496-223420, 1496-223421, 1496-223422, 1496-223423, 1496-223424, 1496-223425, 1496-223426, 1496-223427, 1496-223428, 1496-223429, 1496-223430, 1496-223431, 1496-223432, 1496-223433, 1496-223434, 1496-223435, 1496-223436, 1496-223437, 1496-223438, 1496-223439, 1496-223440, 1496-223441, 1496-223442, 1496-223443, 1496-223444, 1496-223445, 1496-223446, 1496-223447, 1496-223448, 1496-223449, 1496-223450, 1496-223451, 1496-223452, 1496-223453, 1496-223454, 1496-223455, 1496-223456, 1496-223457, 1496-223458, 1496-223459, 1496-223460, 1496-223461, 1496-223462, 1496-223463, 1496-223464, 1496-223465, 1496-223466, 1496-223467, 1496-223468, 1496-223469, 1496-223470, 1496-223471, 1496-223472, 1496-223473, 1496-223474, 1496-223475, 1496-223476, 1496-223477, 1496-223478, 1496-223479, 1496-223480, 1496-223481, 1496-223482, 1496-223483, 1496-223484, 1496-223485, 1496-223486, 1496-223487, 1496-223488, 1496-223489, 1496-223490, 1496-223491, 1496-223492, 1496-223493, 1496-223494, 1496-223495, 1496-223496, 1496-223497, 1496-223498, 1496-223499, 1496-223500, 1496-223501, 1496-223502, 1496-223503, 1496-223504, 1496-223505, 1496-223506, 1496-223507, 1496-223508, 1496-223509, 1496-223510, 1496-223511, 1496-223512, 1496-223513, 1496-223514, 1496-223515, 1496-223516, 1496-223517, 1496-223518, 1496-223519, 1496-223520, 1496-223521, 1496-223522, 1496-223523, 1496-223524, 1496-223525, 1496-223526, 1496-223527, 1496-223528, 1496-223529, 1496-223530, 1496-223531, 1496-223532, 1496-223533, 1496-223534, 1496-223535, 1496-223536, 1496-223537, 1496-223538, 1496-223539, 1496-223540, 1496-223541, 1496-223542, 1496-223543, 1496-223544, 1496-223545, 1496-223546, 1496-223547, 1496-224427, 1496-224428, 1496-224449, 1496-224450, 1496-224451, 1496-224452, 1496-224453, 1496-224454, 1496-224455, 1496-224456, 1496-224457, 1496-224458, 1496-224459, 1496-224460, 1496-224461, 1496-224462, 1496-224463, 1496-224464, 1496-224465, 1496-224466, 1496-224467, 1496-224468, 1496-224469, 1496-224470, 1496-224471, 1496-224472, 1496-224473, 1496-224474, 1496-224475, 1496-224476, 1496-224477, 1496-224478, 1496-224479, 1496-224480, 1496-224481, 1496-224482, 1496-224483, 1496-
- Hazard
- Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
More from Spacelabs Healthcare
See all- Spacelabs Xhibit Central Station recalled over DisplayPort splitter failure
ModerateFDAAug 19, 2026