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.
FDA Recall Z-0949-2013 · Posted 2013-03-14
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Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeIOQ
Date Initiated2013-02-26
Date Terminated2014-04-16
Product Quantity309
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,
Firm Action
Hill-Rom sent an Urgent Field Safey Notice letter dated February 26, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter advised customers to follow steps provided until the updated software is available. Customers were requested to forward a copy of this letter to any other facility personnel you deem appropriate. Questions should be directed to Hill-Rom Technical Support at 800-445-3720
Root Cause
Software design
Distribution Pattern
USA Nationwide Distribution including the state of Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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