Recall Z-0949-2013— Hill-Rom, Inc.

Name: FDA recall Z-0949-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-26

Class II · Terminated

Class II FDA medical device recall by Hill-Rom, Inc., initiated 2013-02-26, terminated 2014-04-16. It names one FDA 510(k) clearance: K970636. 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: 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,.

Recalling firm: Hill-Rom, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Terminated: 2014-04-16
Firm location: Batesville, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K970636 — TOTALCARE., MODULAR THERAPY SYSTEM (MTS)Hill-Rom, Inc.·cleared 1997-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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,

Data sourced from openFDA. This site is unofficial and independent of the FDA.