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FDAFDA · Food and drugs·Recall number Z-2737-2020

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.

Published August 5, 2020 · Recall initiated: June 30, 2020

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Hill-Rom, Inc.
Distributor
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.
Lot
Serial Numbers Affected: V133AW9885 through V142AW0261and manufactured between May 12, 2020 and May 21, 2020
Risk classification
Class II
Area (FDA)
device
Country
United States

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