| | Class 2 Recall
TotalCare SpO2RT® 2 bed |  |
| Date Posted |
March 14, 2013 |
| Recall Number |
Z-0949-2013 |
| 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. |
| Code Information |
S/N between N230AM1358 & O023AM3687.
|
Recalling Firm/
Manufacturer |
Hill-Rom, Inc.
1069 State Route 46 East
Batesville, Indiana 47006-7520 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Jeff Moster
812-934-7777
|
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,
|
| 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 in Commerce |
309 |
| Distribution |
USA Nationwide Distribution including the state of Canada |
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