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Recall Observatory FDA recall evidence

Device 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.

Z-2738-2020

June 30, 2020

Class II

Product summary

Firm
Hill-Rom, Inc.
Event
Event 85925
Status
Terminated
Classification
Class II
Quantity
1033
Official record key
device-enforcement:Z-2738-2020

Official wording

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.

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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.