Hill-Rom, Inc. recalls Progressa Bed, Catalog No. P7500 - Product Usage: intended to be used to treat or prevent pulmonary or other complicati…

Recall date

June 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2737-2020

FDA classification

Class II

Brand / firm

Hill-Rom, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Progressa Bed, Catalog No. P7500 - 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.