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.
This recall has been terminated (originally issued March 14, 2013).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- February 26, 2013
- Posted
- March 14, 2013
- Terminated
- April 16, 2014
- Recall Number
- Z-0949-2013
- Quantity
- 309
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
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
USA Nationwide Distribution including the state of Canada
Lot / Code Info
S/N between N230AM1358 & O023AM3687.
Root Cause
Software design
Action Taken
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