Data Foundry

Medical device recalls 2013

TotalCare SpO2RT2 bed — Class II medical device recall Z-0949-2013

Terminated recall by Hill-Rom, Inc., reported 2013-03-20, distributed nationwide. In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadverte

Recall numberZ-0949-2013
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHill-Rom, Inc., Batesville, IN, United States
Recall initiated2013-02-26
Classified2013-03-14
Reported by FDA2013-03-20
Terminated2014-04-16
DistributedNationwide (US)
Countries outside the USCA
Quantity309
Reason classessoftware

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 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.

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,

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0949-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.