Z-0949-2013 Class II Terminated
FDA device recall Z-0949-2013 was initiated by Hill-Rom, Inc. on Feb 26, 2013 and is designated Class II. 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… The recall status is terminated (terminated Apr 16, 2014). Affected quantity: 309.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2013
- Initiation Date
- Feb 26, 2013
- Termination Date
- Apr 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 309
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,
Distribution Pattern
USA Nationwide Distribution including the state of Canada
Code Information
S/N between N230AM1358 & O023AM3687.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0949-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026