The Recall Desk
HighFDA (Devices)·Z-1794-2013·Announced 2013-07-31

Hill-Rom TotalCare Bed Recall Due to Mattress Egress Injury Risk

Hill-Rom is recalling 4,121 TotalCare Beds because the mattress may not stay flat in the chair egress position, creating a risk of patients falling or sliding to the floor.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Hill-Rom, Inc. is recalling 4,121 units of the TotalCare Bed System used with AccuMax Quantum VPC, Complete, and Convertible mattresses. The recall covers beds distributed worldwide, including the United States, Canada, Colombia, Nigeria, Kuwait, and Saudi Arabia. The affected mattresses were distributed between September 2005 and April 2013.

The recall is issued because when the bed is placed in the chair egress position, the magnets on the mattress may fail to hold the bottom of the mattress flat against the bed frame. This causes the foot section of the mattress to extend away from the bed at an angle. A patient attempting to return to the bed may miss the seat and sit on the foot section instead, potentially sliding down to the floor or falling, which could result in injury.

Health care facilities and consumers should stop using the affected TotalCare Bed Systems immediately. Hill-Rom, Inc. is the recalling firm and will provide instructions for the recall.

The recalled product

Product
TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System m
Manufacturer
Hill-Rom, Inc.
Affected units
4,121

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (13)

  • Bed model numbers: PAU001010784
  • PAU005010784
  • P1900
  • PAK169N10184
  • PAK169N10384
  • PA8171210184
  • PA8175210184
  • PA8175210384
  • PA8171210384
  • PA8171310384
  • and PA8173210384. The AccuMax Quantum VPC
  • Complete and Convertible mattresses are not serialized
  • but were distributed between September 2005 and April 2013

Distribution

Distributed nationwide across the United States.