Class 2 Device Recall Progressa Bed

• Date Initiated by Firm: June 30, 2020
• Create Date: July 30, 2020
• Recall Status: Terminated on October 20, 2022
• Recall Number: Z-2737-2020
• Recall Event ID: 85925
• Product Classification: Bed, ac-powered adjustable hospital - Product Code FNL
• Product: Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either Continuous Lateral Rotation Therapy or Percussion/Vibration Therapy.
• Code Information: Serial Numbers Affected: V133AW9885 through V142AW0261and manufactured between May 12, 2020 and May 21, 2020
• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 1069 State Road 46 E; Batesville IN 47006-7520
• For Additional Information Contact: Hill Rom Technical Support; 800-445-3720
• Manufacturer Reason for Recall: Affected beds may have screws installed that do not meet material tensile strength requirements. Failure of this screw could result in serious patient or user injury.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On June 30, 2020, the firm mailed Urgent Medical Device Correction Notice letters to affected customers. Customers received letters with Centrella Smart+ Beds or Progressa Beds in the subject line depending on which affected products they had received. Customers were informed of the potential safety issue regarding nonconforming screws used in the beds, which may cause the frame to fail and lead to serious injury to the patient. Customers were instructed to do the following: 1. Until your affected beds are updated, Hill-Rom is urging customers to follow the instructions outlined below: -Caution your users that when utilizing the bed articulation functions, if there is any binding during movement or deformation in the frame, to take the bed immediately out of service until the bed is updated. -Follow the safety information as outlined in the Instructions for Use each time when setting the brakes. If the brakes do not hold after following the instructions, immediately take the bed out of service until the bed is updated. -Caution your users that after placing the bed in steer mode and beginning transport, if there is any difficulty with aligning one of the casters in the trailing position and maintaining control, take the bed immediately out of service until the bed is updated. -Follow the Instructions for Use each time when raising a siderail to the latched position. If the siderails are not latching properly, take the bed immediately out of service until the bed is updated. 2. Complete the response form attached to the notification and return it to Hill-Rom. 3. Contact Hill-Rom at 800-445-3720 or us.service@hillrom.com if you have any questions. 4. Hill-Rom will be reaching out to you to assist with the planning of your bed(s) correction. Hill Rom will follow-up with a phone call if they have not received a reply within 10 days. Hill-Rom will contact you to schedule your correction. The correction will need to be completed without a patient
• Quantity in Commerce: 257
• Distribution: Worldwide distribution - US nationwide distribution including in the states of AR, AZ, CA, DE, IN, KY, MD, ME, MI, MO, NC, NM, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV and the country of Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.