Recall Z-2738-2020 ยท FNL Bed, Ac-Powered Adjustable Hospital
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.
| Date | Jun 30, 2020 |
| Status | Terminated |
| 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: -Cau |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.