FDA-Device2020-08-05Class II
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.
Hill-Rom, Inc.
Hazard
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.
Sold states
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.
Affected count
1033
Manufactured in
1069 State Road 46 E, N/A, Batesville, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2738-2020Don't want to check this manually?
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