Events

Recall of Device Recall Ultraview SL Command Module/Multiparameter input module

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
    37077
  • Event Risk Class
    Class 2
  • Event Number
    Z-0523-2007
  • Event Initiated Date
    2007-01-03
  • Event Date Posted
    2007-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49866
  • 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
    multiparameter patient monitor - Product Code DSI
  • Reason
    Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and sp02 alarm limits being frozen. this can result in delay in treatment.
  • Action
    On 1/3/07 the firm issued a letter to their customers advising of the issues and provided guidance to the consignee to enable the Check Setup feature that will provide an audible prompt whenever the monitor resets. The letter advises that consignees will be contacted to schedule an update, once new software has been validated.

Device

Device Recall Ultraview SL Command Module/Multiparameter input module
  • Model / Serial
    Serial numbers 1496-004112, 1496-005720, 1496-004094, 1496-004088, 1496-004089, 1496-004090, 1496-004091, 1496-004092, 1496-004093, 1496-004110, 1496-011601, 1496-004111, 1496-010974, 1496-010975, 1496-010977, 1496-011021, 1496-004174, 1496-004175, 1496-004177, 1496-004178, 1496-004179, 1496-004180, 1496-004165, 1496-004166, 1496-009201, 1496-006236, 1496-006432, 1496-006434, 1496-008163, 1496-008164, 1496-005413, 1496-011026, 1496-006435, 1496-006436, 1496-006829, 1496-006830, 1496-006831, 1496-006832, 1496-006895, 1496-006912, 1496-006913, 1496-006914, 1496-009137, 1496-009138, 1496-004108, 1496-004109, 1496-005761, 1496-008497, 1496-008498, 1496-008499, 1496-008500, 1496-008501, 1496-010056, 1496-010057, 1496-005369, 1496-005388, 1496-005412, 1496-010607, 1496-010053, 1496-005254, 1496-005255, 1496-005256, 1496-005257, 1496-005258, 1496-005326, 1496-005327, 1496-005328, 1496-005329, 1496-004075, 1496-004076, 1496-004077, 1496-004078, 1496-004079, 1496-004080, 1496-004081, 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  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide and worldwide.
  • Product Description
    Ultraview SL Command Module with Masimo Sp02 Option, a multiparameter patient monitor.
  • Manufacturer
    Spacelabs Healthcare, Incorporated

Manufacturer

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