Hill-Rom, Inc.: Centrella Smart+ Bed, Catalog No. P7900 - 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.

Recall number

Z-2738-2020

Recalling firm

Hill-Rom, Inc.

Product

Centrella Smart+ Bed, Catalog No. P7900 - 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.

Status

Terminated

Initiated

2020-06-30

Posted

not on file

Terminated

2022-10-20

Reason

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.

Root 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

1033

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.

Lot, serial or model codes

Serial Numbers Affected: V133PF2502 through V142PF3819 and manufactured between May 12, 2020 and May 21, 2020

510(k) numbers

not on file

PMA numbers

not on file

Product code

FNL

Firm FEI

1824206

Firm city

Batesville

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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