BEUDAMED
    FDA Recall Terminated

    2000 Vascular with 30 Degree option

    Recall: Z-0353-2020 · Initiated September 2, 2016

    Recall

    Recall Number
    Z-0353-2020
    Event Number
    83219
    Firm
    Heritage Medical Products, Inc.
    FEI Number
    3003881889
    Product Code
    LGX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 2, 2016
    Terminated
    December 14, 2020
    Address
    10380 County Road 6310, West Plains, MO, 65775-6331

    Description

    2000 Vascular with 30 Degree option

    Reason

    Potential for bed to drop suddenly at the head while a patient is laying on it.

    Action

    Heritage Medical Products, Inc. notified customers on about 09/02/2016 via "Advisory Notice." Customers were informed that Heritage Medical has designed a reinforcement kit as a correction, which will be supplied to customers. Customers were instructed to contact Heritage Medical, provide the serial number of their bed to ensure it is affected, and Heritage Medical will provide a free kit that will reinforce the area on the affected devices that has experienced failures. The contact information is a follows: Heritage Medical Products, Inc., ATTN.: Trunnion Reinforcement Kit, 10380 CR 6310, West Plains, MO 65775, (888) 256-8748.

    Distribution

    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, OH, OK, OR, PA, SC, TX, UT, VA, WI, WY, PR. International distribution to Canada, Saudi Arabia, Trinidad & Tobago.

    Quantity

    167 beds (159 US, 8 OUS)