Events

Recall of Device Recall Ultraview SL 2200

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Spacelabs Healthcare, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53779
  • Event Risk Class
    Class 2
  • Event Number
    Z-0647-2010
  • Event Initiated Date
    2009-11-06
  • Event Date Posted
    2010-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86500
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Medical Cathode-Ray Tube Display - Product Code DXJ
  • Reason
    Potential for monitor to shut down and not being able to power on again.
  • 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.

Device

Device Recall Ultraview SL 2200
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    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.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

Spacelabs Healthcare, Incorporated
  • Manufacturer Address
    Spacelabs Healthcare, Incorporated, 5150 220th Ave Se, Issaquah WA 98029-6834
  • Source
    USFDA