CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

TotalCare SpO2RT2 bed recalled by Hill-Rom

Hill-Rom is recalling TotalCare SpO2RT2 bed, distributed nationwide in the US. The recall was initiated on 26 Feb 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesS/N between N230AM1358 & O023AM3687.

Quantity recalled309

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0949-2013
FDA event ID: 64580
Recalling firm: Hill-Rom, Batesville, IN
Classification: Class II
Status: Terminated
Recall initiated: 26 Feb 2013
FDA classified: 14 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Lead & Heavy Metals
Device type: Surgical Instruments

Timeline

26 Feb 2013	Recall initiated by company
14 Mar 2013	Classified by FDA	+16 days
20 Mar 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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,

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

TotalCare SpO2RT2 bed. Product Usage: Bed, 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.

Where it was distributed

USA Nationwide Distribution including the state of Canada

Nationwide

Stores named: Walmart

Questions about this recall

Is TotalCare SpO2RT2 bed recalled?

Yes. Hill-Rom recalled TotalCare SpO2RT2 bed on 26 Feb 2013. The recall is Class II and its status is Terminated. Recall number Z-0949-2013.

Why was it recalled?

Which lots are affected?

S/N between N230AM1358 & O023AM3687.

Where was it sold?

USA Nationwide Distribution including the state of Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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