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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 64580
Product Type Devices
Status Ongoing
Recalling Firm Hill-Rom, Inc.
City Batesville
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-02-26
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationwide Distribution including the state of Canada

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. S/N between N230AM1358 & O023AM3687. Class II 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, and will be released within thirty (30) days. 309 Z-0949-2013