Reported Mar 20, 2013 · Terminated

TotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings…

Hill-Rom, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Hill-Rom, Inc. · 1069 State Route 46 East · Batesville, IN · 47006-7520

Is this the product you have?

  • TotalCare SpO2RT2 bed
  • Product UsageBed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT¿ 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution
Lot codes and dates
  • S/N between N230AM1358 & O023AM3687.
Amount recalled
309

Where it was sold

  • Nationwide

Why it was recalled

In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 16, 2014 · Data as of Sep 19, 6:54 PM UTC

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