Recall Z-0949-2013 ยท IOQ Bed, Flotation Therapy, Powered
Hill-Rom, Inc.
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 wit
| Date | Mar 14, 2013 (initiated Feb 26, 2013) |
| Status | Terminated |
| 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, |
| Root cause | Software design |
| 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 |
| Quantity | 309 |
| Distribution | USA Nationwide Distribution including the state of Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K970636 | TOTALCARE., MODULAR THERAPY SYSTEM (MTS) Hill-Rom, Inc., Aug 26, 1997 |