BEUDAMED
    FDA Recall Terminated

    Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed.

    Recall: Z-1326-2009 · Initiated December 22, 2008

    Recall

    Recall Number
    Z-1326-2009
    Event Number
    50740
    Firm
    Smiths Medical PM, Inc. N7
    FEI Number
    2183502
    Product Code
    CCK
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 22, 2008
    Posted
    May 15, 2009
    Terminated
    December 17, 2011
    Address
    W22025 Johnson Dr, Waukesha, WI, 53186-1856

    Description

    Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed.

    Reason

    Recent improvements were made to the Advisor case plastic resulting in the inserts being deeply embedded into the plastic. This affects the ability of the monitor to be adequately secured on the wall mount bracket or roll stand bracket, resulting in the monitor falling off. There have been no adverse events or injuries reported.

    Action

    An Urgent Product Safety Information, Voluntary Recall Notification, dated 12/22/08, was sent to affected consignees. The notification contained a Safety Action Bulletin which provided actions to be taken. The Safety Action Bulletin described the issue, requested customer to contact Smiths Medical to ensure proper mounting hardware is utilized for those consignees using a roll stand or wall mount. If the consignee further distributed the product, they were asked to forward on the Safety Action Bulletin to the end user. Page 3 of the Safety Action Bulletin was asked to be completed and returned to Smiths Medical PM, Inc. A second "Urgent Product safety Information Voluntary Recall Notification" letter dated January 16, 2009 was sent to consignees. The second letter included a risk statement associated with the recalled product.

    Distribution

    Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Kingdom, and Uruguay.

    Quantity

    143 monitors (17 US, 126 OUS)