Date Initiated by Firm |
February 26, 2013 |
Date Posted |
March 14, 2013 |
Recall Status1 |
Terminated 3 on April 16, 2014 |
Recall Number |
Z-0949-2013 |
Recall Event ID |
64580 |
510(K)Number |
K970636
|
Product Classification |
Bed, flotation therapy, powered - Product Code IOQ
|
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 IN 47006-7520
|
For Additional Information Contact |
Jeff Moster 812-934-7777
|
Manufacturer 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,
|
FDA Determined Cause 2 |
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 in Commerce |
309 |
Distribution |
USA Nationwide Distribution including the state of Canada |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = IOQ and Original Applicant = HILL-ROM, INC.
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