Events

Recall of Ultraview SL Command Modules, Model 91496M, upgraded with the Masimo SpO2 Option

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

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
    71074
  • Event Risk Class
    Class 2
  • Event Number
    Z-1542-2015
  • Event Initiated Date
    2015-04-17
  • Event Date Posted
    2015-04-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136025
  • 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
    Detector and alarm, arrhythmia - Product Code DSI
  • Reason
    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.
  • Action
    Spacelabs Healthcare sent an Urgent - Medical Device Correction letter, dated 17 April 2015, to the US consignees via priority mail. On 4/24/2015, the firm will send the Urgent - Medical Device Correction letter (translated as necessary) via email to international subsidiaries and distributor of record. The Identified the affected product, problem and actions to be taken. Ultraview SL Command Modules which were upgraded with the Masimo SpO2 Option, Model 91496-M are affected. Ultraview SL Command Modules originally shipped with Masimo SpO2 are NOT affected. Spacelabs Healthcare will contact you to schedule a convenient time for Spacelabs to correct all of your facility's affected Command Modules at no cost. For additional information or technical assistance, please contact: Technical Support Spacelabs Healthcare, Inc. 35301 SE Center St. Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support

Device

Ultraview SL Command Modules, Model 91496M, upgraded with the Masimo SpO2 Option
  • Model / Serial
    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, 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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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    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.
  • Product Description
    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.
  • Manufacturer
    Spacelabs Healthcare Inc

Manufacturer

Spacelabs Healthcare Inc
  • Manufacturer Address
    Spacelabs Healthcare Inc, 35301 SE Center St, Snoqualmie WA 98065-9216
  • Manufacturer Parent Company (2017)
    OSI Systems Inc
  • Source
    USFDA