Agency classClass IIOur severity:High FDA (Devices)·Z-0949-2013·Announced 2013-03-20

Hill-Rom TotalCare SpO2RT2 Bed Recalled for Software Pressure Issue

Hill-Rom is recalling 309 TotalCare SpO2RT2 beds due to a software defect that may reduce surface cushion pressure, potentially increasing the risk of skin irritation for high-risk patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 (medical device) where injury (skin irritation) has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Hill-Rom, Inc. is recalling 309 units of the TotalCare SpO2RT2 bed. These powered beds are used in various healthcare settings, including acute care, critical care, step-down units, medical/surgical wards, sub-acute care, post-anesthesia care units, and emergency departments. The affected units have serial numbers between N230AM1358 and O023AM3687. The recall covers distribution across the United States and Canada.

The recall is due to a software problem that may cause an inadvertent loss of sufficient surface cushion pressure. This issue may fail to adequately support the patient, which increases the likelihood of skin irritation for patients who are at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested.

Healthcare facilities and consumers should identify affected units by checking the serial number. The manufacturer is working on a software fix to address the pressure support issue.

The recalled product

Product: 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…
Manufacturer: Hill-Rom, Inc.
Category: Medical Device — Hospital Bed
Hazard: pressure-injury
software-defect
Affected units: 309

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 (1)

S/N between N230AM1358 & O023AM3687.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Hill-Rom, Inc.

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