BEUDAMED
    FDA Recall Terminated

    Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds

    Recall: Z-1131-2012 · Initiated February 3, 2012

    Recall

    Recall Number
    Z-1131-2012
    Event Number
    60888
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    INX
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 3, 2012
    Posted
    March 1, 2012
    Terminated
    December 5, 2012
    Address
    1069 State Route 46 East, Batesville, IN, 47006-7520

    Description

    Clinitron At Home Bed headboard and foot side rails. The Clinitron At Home Air Fluidized Therapy Unit provides a pressure-relieving sleep surface for patients in the home environment. It helps enable patients with pressure sores to heal their wounds

    Reason

    The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed headboards failed to meet the safety standard force requirements. The firm identified in October 2011 that the Clinitron Rite Hite Bed and Clinitron At Home Bed outer rail, which is extruded Aluminum tubing, is intended to be one piece joined together by a weld at the lower center. The parts receiv

    Action

    Hill-Rom, Inc. sent a Modification Notice Urgent Medical Device Correction Notification dated February 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The modification notice instructed all customers to find and replace all headboards and food side rails that do not meet design intent. All technicians will inspect all affected product in the service centers and all at home and rite hite beds for an "x" or "L" stamp. The technicians will inspect the beds that are still in use during scheduled maintenance or before each rental. All will be completed before 01-JUL-12. For support call 1-800-445-3720

    Distribution

    Worldwide Distribution -- USA (nationwide) including the states of AL, AK, AZ, AR, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VA, WA, WI, WV, and WY. and the country of Canada.

    Quantity

    Foot Siderail = 70; Headboards = 103