BEUDAMED
    FDA Recall Terminated

    Pelton & Crane Spirit 1800 dental chair (Model #SP18)

    Recall: Z-1851-2011 · Initiated March 4, 2011

    Recall

    Recall Number
    Z-1851-2011
    Event Number
    58105
    Firm
    Pelton & Crane Company
    FEI Number
    1017522
    Product Code
    NRU
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 4, 2011
    Posted
    March 30, 2011
    Terminated
    August 16, 2011
    Address
    11727 Fruehauf Dr, Charlotte, NC, 28273

    Description

    Pelton & Crane Spirit 1800 dental chair (Model #SP18)

    Reason

    The Link Arm Assembly that connects some rear mounted options to the Spirit 3000 or Spirit 1800 dental chairs may potentially break and fall off the dental chair.

    Action

    Pelton & Crane sent an "Urgent Medical Device Recall" letter dated 3/04/2011. They were instructed to: Locate the affected devices this recall is in regards to. Schedule service with the end user for Pelton & Crane representative to replace the affected components this recall is in regards to. International accounts were instructed to order link arm assemblies from Pelton & Crane and replace the affected components. All consignees were to complete the Recall Acknowledgement/Return Form and return the form to Pelton & Crane.

    Distribution

    Distribution to USA, Canada, and the Netherlands.

    Quantity

    6 units