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
- Recall Number
- Z-2738-2020
- Event Number
- 85925
- Firm
- Hill-Rom, Inc.
- FEI Number
- 1824206
- Product Code
- FNL
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- June 30, 2020
- Terminated
- October 20, 2022
- Address
- 1069 State Road 46 E, Batesville, IN, 47006-7520
Description
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.
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.
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 [email protected] 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
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.
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