BEUDAMED
    FDA Recall Terminated

    Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection.

    Recall: Z-2916-2011 · Initiated July 6, 2011

    Recall

    Recall Number
    Z-2916-2011
    Event Number
    59441
    Firm
    Spacelabs Healthcare, Llc
    FEI Number
    3010157426
    Product Code
    MHX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    July 6, 2011
    Posted
    August 2, 2011
    Terminated
    January 25, 2012
    Address
    5150 220th Ave Se, Issaquah, WA, 98029-6834

    Description

    Vital Sign elance Monitor, Model 93300 Spacelabs Healthcare, Llc. A vital signs patient monitor with arrhythmia detection.

    Reason

    Model 93300 Vital Signs Monitor may stop operating while in use, and when this occurs, the monitor may also fail to power ON. The resulting situation may cause a loss of monitoring for the patient.

    Action

    Spacelabs Healthcare, Llc sent an "Urgent-Medical Device Correction" letter dated 18 July 2011 to all affected customers. The letter notified the customers of the problem and recommended customers make their staff aware. It also informed them a Field Service Engineer will contact them to check, and if necessary make adjustments. Customers can contact Spacelabs Healthcare at 800-522-7025 and select 2 for Technical Support or outside the U.S. at +86512-8717-1888, extension 304.

    Distribution

    Worldwide Distribution: (USA) Nationwide distribution including the state of WI, and the countries of Puerto Rico, Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Chile, China, Colombia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, France, Germany, Greece, Guatemala, Honduras, Hong Kong, India, Indonesia, Iraq, Israel, Italy, Kenya, Korea, Kuwait, Lebanon, Malaysia, Napel, Netherlands, Nicaragua, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Republic of Macedonia, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sri Lanka, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Tunisia, Turkey, UAE, United Kingdom, Venezuela, and Vietnam.

    Quantity

    1970 units