Spacelabs Healthcare, Llc: Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.

Recall number

Z-3036-2011

Recalling firm

Spacelabs Healthcare, Llc

Product

Product is the Ultraview Spacelabs Compact monitor, models 91367, 91369, and 91370, with touch screen display and wireless option. Product Usage: Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwired or wireless transmission.. Through this network, a patients data may be displayed at the bedside monitor, central station or a clinical information system.

Status

Terminated

Initiated

2010-09-17

Posted

2011-08-18

Terminated

2011-08-22

Reason

Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem.

Root cause

Software design

Action

Spacelabs Medical sent an "URGENT - MEDICAL DEVICE CORRECTION" notification letter to U.S. consignees by mail on September 17, 2010 and to international consignees by e-mail on September 24, 2010. The letter identified the recalled product, warns customers of the potential hazard and identifies some ways to mitigate the risk if they decide to continue use. The letter states to correct this situation, the recalling firm Field Service Engineers will be contact customers to schedule a time to install a free software update. If customers have any questions about this corrective action program, please contact Spacelabs Medical at 1-800-522-7025 and select 2 for Technical Support, or outside the United States 1-425-657-7200 x5089.

Quantity

579 total (517 to US acc'ts; 62 to international acct's.

Distribution

Worldwide Distribution - USA (nationwide) and the countries of: International distribution to: Canada, China, France, Germany, Italy, and the United Kingdom.

Lot, serial or model codes

SERIAL NUMBERS: 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 040-1572-00, 1367-000112, 1367-000113, 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, 1367-000778, 1367-000782, 1367-000783, 1367-000784, 1367-000785, 1367-000787, 1367-000788, 1367-000792, 1367-000794, 1367-000795, 1367-000796, 1367-000797, 1367-000801, 1367-000802, 1367-000803, 1367-000804, 1367-000805, 1367-000806, 1367-000807, 1367-000808, 1367-000809, 1367-000810, 1367-000811, 1367-000812, 1367-000814, 1367-000815, 1367-000817, 1367-000818, 1367-000819, 1367-000831, 1367-000832, 1367-000833, 1367-000876, 1367-000877, 1367-000889, 1367-000890, 1367-000969, 1367-000996, 1367-000997, 1367-001046, 1367-001047, 1367-001069, 1367-001094, 1367-001095, 1367-001096, 1367-001097, 1367-001098, 1367-001099, 1367-001100, 1367-001138, 1367-001139, 1367-001140, 1367-001141, 1367-001142, 1367-001143, 1367-001144, 1367-001145, 1367-001146, 1367-001147, 1367-001148, 1367-001149, 1367-001150, 1367-001151, 1367-001152, 1367-001153, 1367-001154, 1367-001155, 1367-001156, 1367-001157, 1367-001158, 1367-001159, 1367-001175, 1367-001176, 1367-001177, 1369-003807, 1369-004493, 1369-004494, 1369-004495, 1369-004496, 1369-005181, 1369-005182, 1369-008556, 1369-008561, 1369-008562, 1369-008699, 1369-008700, 1369-008701, 1369-008702, 1369-008703, 1369-008704, 1369-008705, 1369-008706, 1369-008707, 1369-008721, 1369-008829, 1369-008830, 1369-008831, 1369-008832, 1369-008833, 1369-008834, 1369-008835, 1369-008836, 1369-008837, 1369-008838, 1369-008839, 1369-008841, 1369-008842, 1369-008843, 1369-008844, 1369-008845, 1369-008846, 1369-008847, 1369-008848, 1369-008850, 1369-008851, 1369-008852, 1369-008853, 1369-008854, 1369-008858, 1369-008881, 1369-008884, 1369-009247, 1369-009591, 1369-009592, 1369-009593, 1369-009594, 1369-009595, 1369-009789, 1369-009793, 1369-009794, 1369-009946, 1369-010098, 1369-011656, 1369-011657, 1369-011658, 1369-011659, 1369-011681, 1369-012491, 1369-012492, 1369-012493, 1369-012494, 1369-012764, 1369-012765, 1369-012773, 1369-012824, 1369-012825, 1369-012826, 1369-012827, 1369-012843, 1369-012856, 1369-012950, 1369-012952, 1369-012953, 1369-012954, 1369-012955, 1369-012956, 1369-012972, 1369-012973, 1369-012974, 1369-012975, 1369-013045, 1369-013046, 1369-013047, 1369-013178, 1369-013179, 1369-013180, 1369-013181, 1369-013182, 1369-013183, 1369-013184, 1369-013185, 1369-013186, 1369-013187, 1369-013188, 1369-013189, 1369-013190, 1369-013191, 1369-013192, 1369-013193, 1369-013194, 1369-013195, 1369-013197, 1369-013198, 1369-013206, 1369-013207, 1369-013208, 1369-013209, 1369-013210, 1369-013211, 1369-013212, 1369-013213, 1369-013347, 1369-013348, 1369-013349, 1369-013350, 1369-013351, 1369-013352, 1369-013353, 1369-013355, 1369-013356, 1369-013357, 1369-013358, 1369-013359, 1369-013360, 1369-013522, 1369-013523, 1369-013524, 1369-013529, 1369-013530, 1369-013531, 1369-013532, 1369-013533, 1369-013534, 1369-013535, 1369-013536, 1369-013537, 1369-013615, 1369-013616, 1369-013617, 1369-013618, 1369-013619, 1369-013620, 1369-013621, 1369-013622, 1369-013623, 1369-013624, 1369-013625, 1369-013626, 1369-013627, 1369-013628, 1369-013629, 1369-013630, 1369-013632, 1369-013731, 1369-013732, 1369-013733, 1369-013734, 1369-013735, 1369-013846, 1369-013901, 1369-013902, 1369-013903, 1369-013904, 1369-013905, 1369-013906, 1369-013907, 1369-013908, 1369-013965, 1369-013966, 1369-014163, 1369-014164, 1369-014165, 1369-014166, 1369-014167, 1369-014168, 1369-014169, 1369-014170, 1369-014171, 1369-014172, 1369-014173, 1369-014174, 1369-014228, 1369-014229, 1369-014238, 1369-014290, 1369-014291, 1369-014292, 1369-014293, 1369-014294, 1369-014295, 1369-014297, 1369-014298, 1369-014299, 1369-014300, 1369-014359, 1369-014360, 1369-014493, 1369-014542, 1369-014550, 1369-014598, 1369-014613, 1369-014640, 1369-014641, 1369-014642, 1369-014660, 1369-014661, 1369-014662, 1369-014663, 1369-014664, 1369-014669, 1369-014670, 1369-014671, 1369-014867, 1369-014868, 1369-014910, 1369-014911, 1369-014912, 1369-014913, 1369-014914, 1369-014916, 1369-014917, 1369-014918, 1369-014919, 1369-014920, 1369-014921, 1369-014922, 1369-014923, 1369-014924, 1369-014925, 1369-014926, 1369-014927, 1369-014928, 1369-014929, 1369-014930, 1369-014931, 1369-014932, 1369-014933, 1369-014934, 1369-014938, 1369-014939, 1369-014940, 1369-014941, 1369-014942, 1369-014943, 1369-014944, 1369-014945, 1369-014947, 1369-014948, 1369-014959, 1369-014977, 1369-014996, 1369-014998, 1369-014999, 1369-015000, 1369-015013, 1369-015041, 1369-015114, 1370-000015, 1370-000695, 1370-000696, 1370-000697, 1370-000698, 1370-000699, 1370-000700, 1370-000701, 1370-002517, 1370-003328, 1370-003329, 1370-003330, 1370-003331, 1370-003332, 1370-003333, 1370-003335, 1370-003336, 1370-003337, 1370-003338, 1370-003339, 1370-003370, 1370-003371, 1370-003372, 1370-003373, 1370-003374, 1370-003375, 1370-003376, 1370-003377, 1370-003378, 1370-003379, 1370-003380, 1370-003381, 1370-003382, 1370-003384, 1370-003385, 1370-003386, 1370-003387, 1370-003388, 1370-003390, 1370-003391, 1370-003392, 1370-003393, 1370-003394, 1370-003395, 1370-003396, 1370-003397, 1370-003972, 1370-003973, 1370-003974, 1370-003975, 1370-003976, 1370-003977, 1370-003978, 1370-004022, 1370-004203, 1370-004207, 1370-004216, 1370-004217, 1370-004265, 1370-004266, 1370-004467, 1370-004530, 1370-004545, 1370-004546, 1370-004547, 1370-004548, 1370-004549, 1370-004550, 1370-004551, 1370-004552, 1370-004553, 1370-004554, 1370-004555, 1370-004556, 1370-004557, 1370-004558, 1370-004559, 1370-004560, 1370-004561, 1370-004617, 1370-004720, 1370-004721, 1370-004722, 1370-004723, 1370-004724, 1370-004725, 1370-004726, 1370-004727, 1370-004728, 1370-004730, 1370-004731, 1370-004732, 1370-004733, 1370-004751, 1370-004770, 1370-004771, 1370-004772, 1370-004773, 1370-004774, 1370-004775, 1370-004858, 1370-004859, 1370-004872, 1370-004873, 1370-004874, 1370-004875, 1370-004876, 1370-004877, 1370-004878, 1370-004879, 1370-004880, 1370-004881, 1370-004882, 1370-004883, 1370-004884, 1370-004885, 1370-004886, 1370-004887, 1370-004888, 1370-004889, 1370-004890, 1370-004891, 1370-004892, 1370-004893, 1370-004894, 1370-004895, 1370-004896, 1370-004897, 1370-004898, 1370-004899, 1370-004900, 1370-004901, 1370-004902, 1370-004903, 1370-004904, 1370-004905, 1370-004906, 1370-004907, 1370-004908, 1370-004909, 1370-004910, 1370-005054, 1370-005055, 1370-005056, 1370-005057, 1370-005058, 1370-005059, 1370-005060, and 1370-005061.

510(k) numbers

["K972282"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3010157426

Firm city

Issaquah

Firm state

WA

Firm country

not on file

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

Copy