device · product 1 of 1
Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.
- Recall number
- Z-1542-2015
- Initiated
- April 17, 2015
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Spacelabs Healthcare Inc
- Quantity
- 1999 units total (1932 in the US and 67 international)
App-derived interpretation
Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
Reason for recall
Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M was affected. Customer reported that during the time that the module is resetting (~10 seconds), monitoring of all parameters will be suspended. Upon completion of this sequence, alarms will be reset to their default values.
Code information
SERIAL NUMBERS IN THE US: 1496-000473, 1496-000590, 1496-001126, 1496-001189, 1496-001214, 1496-001299, 1496-001300, 1496-001301, 1496-001302, 1496-001303, 1496-001304, 1496-001305, 1496-001306, 1496-001307, 1496-001309, 1496-001328, 1496-001329, 1496-001330, 1496-001332, 1496-001333, 1496-001335, 1496-001336, 1496-001337, 1496-001712, 1496-001713, 1496-001714, 1496-002442, 1496-002568, 1496-002691, 1496-002743, 1496-002832, 1496-002833, 1496-002834, 1496-002836, 1496-002837, 1496-002838, 1496-002839, 1496-002840, 1496-002841, 1496-002917, 1496-002918, 1496-002919, 1496-002920, 1496-002998, 1496-002999, 1496-003000, 1496-003001, 1496-003002, 1496-003003, 1496-003005, 1496-003006, 1496-003007, 1496-003021, 1496-003022, 1496-003025, 1496-003035, 1496-003036, 1496-003037, 1496-003042, 1496-003043, 1496-003044, 1496-003046, 1496-003049, 1496-003051, 1496-003055, 1496-003158, 1496-003161, 1496-003162, 1496-003163, 1496-003164, 1496-003179, 1496-003187, 1496-003190, 1496-003191, 1496-003192, 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1496-106527, 1496-106528, 1496-106529, 1496-107878, 1496-107882, 1496-107884, 1496-107903, 1496-107904, 1496-107905, 1496-107906, 1496-109257, 1496-109258, 1496-109259, 1496-109260, 1496-109261, 1496-109263, 1496-109264, 1496-109265, 1496-109266, 1496-109267, 1496-109298, 1496-109299, 1496-109300, 1496-109301, 1496-109302, 1496-109303, 1496-109304, 1496-109305, 1496-109306, 1496-109322, 1496-109323, 1496-109324, 1496-109325, 1496-112374, 1496-112632, 1496-117845, 1496-120087, 1496-120088, 1496-120089, 1496-120090, 1496-120091, 1496-120605, 1496-120725, 1496-120726, 1496-120727, 1496-120728, 1496-120729, 1496-120730, 1496-120731, 1496-120732, 1496-120733, 1496-120734, 1496-120757, 1496-120758, 1496-120759, 1496-120760, 1496-120761, 1496-120762, 1496-120763, 1496-120764, 1496-120765, 1496-120766, 1496-120767, 1496-120768, 1496-120769, 1496-121121, 1496-121973, 1496-121974, 1496-121975, 1496-121976, 1496-121977, 1496-121978, 1496-121979, 1496-121980, 1496-121981, 1496-121982, 1496-121983, 1496-121984, 1496-121985, 1496-121986, 1496-121987, 1496-121988, 1496-121989, 1496-121990, 1496-121991, and 1496-121992. **********SERIAL NUMBERS INTERNATIONAL********************************* 1496-001139, 1496-001925, 1496-002364, 1496-002372, 1496-002410, 1496-002411, 1496-002483, 1496-002486, 1496-002501, 1496-002509, 1496-002521, 1496-002542, 1496-002543, 1496-003059, 1496-006322, 1496-006323, 1496-006324, 1496-006702, 1496-009407, 1496-009518, 1496-009550, 1496-009739, 1496-009953, 1496-009979, 1496-010250, 1496-010251, 1496-010257, 1496-010259, 1496-010261, 1496-010779, 1496-011011, 1496-011322, 1496-011553, 1496-011927, 1496-012393, 1496-012715, 1496-012729, 1496-014969, 1496-016724, 1496-017329, 1496-019070, 1496-033510, 1496-038108, 1496-113895, 1496-113896, 1496-113911, 1496-113935, 1496-113936, 1496-113938, 1496-113939, 1496-113940, 1496-113941, 1496-113944, 1496-113945, 1496-113946, 1496-113947, 1496-113948, 1496-113949, 1496-113950, 1496-113951, 1496-113952, 1496-113953, 1496-113954, 1496-113956, 1496-113957, 1496-113958, and 1496-113959.
Distribution pattern
Worldwide Distribution- US Nationwide in the states of AL, DE, GA, ID, IL, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, VA, WA and the country of France.