BEUDAMED
    FDA Recall Terminated

    Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E

    Recall: Z-2156-2021 · Initiated May 28, 2021

    Recall

    Recall Number
    Z-2156-2021
    Event Number
    88185
    Firm
    Hill-Rom, Inc.
    FEI Number
    1824206
    Product Code
    KNC
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 28, 2021
    Terminated
    June 6, 2024
    Address
    1069 State Road 46 E, Batesville, IN, 47006-7520

    Description

    Affinity Four Birthing Bed-used as a birthing bed for women of child bearing age in an LDR (Labor, Delivery, Recovery) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor and Delivery market Model Numbers: P3700B, P3700C, P3700D, & P3700E

    Reason

    Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.

    Action

    Hill Rom Issued Urgent Medical Device Correction Subject: Affinity Four Birthing BedLift-Off Foot Section REF: MOD1331 issued on 05/28/21 to Facility Risk Manager; Facility Administrator; Facility Engineer; Vigilance Manager; Biomedical Engineering; Medical Device Liaison Officer; Distributor, stating reason for recall, health risk and action to take: Verify that the Lift-Off foot section has already been updated with the new Latch Bracket and Foot Section receivers and has adequate engagement into the receivers as noted in the graphics below. Be aware that the foot section has the potential to fall if the latch brackets and foot section receivers have not been updated and are damaged. Refer to Figures 2 and 3 below and complete the following inspection process to determine if your Latch Bracket and Foot Section receiver have adequate engagement. Action to be taken by the distributor: Please share with your end users to instruct them on completing their inspection test outlined above. Complete the attached response form and return to [email protected] without delay. Contact [email protected] to receive an electronic copy of this notification and response form for onward distribution. Hillrom will mitigate this risk through an update to the Lift-Off foot section and will contact you to coordinate the update. Once the product has been updated, some customers who utilize the P278 Hillrom Instrument Tray, may encounter issues fitting the tray. These original version trays will be replaced, as needed, at the time of the update. If you have any questions regarding this safety notice, please contact Hillrom Technical Support at 800-445-3720 or [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, CA, IA, MS, NC, NY, OH, PA, TX, VA and the countries of Australia, Austria, Azerbaijan, Belgium, Chile, China, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Jordan, Kuwait, Netherlands, New Zealand, Norway, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.

    Quantity

    1,096 Beds