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U.S. Department of Health and Human Services

Class 2 Device Recall TotalCare SpO2RT 2 bed

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 Class 2 Recall
TotalCare SpO2RT 2 bed
see related information
Date Posted March 14, 2013
Recall Status1 Terminated on April 16, 2014
Recall Number Z-0949-2013
Recall Event ID 64580
Premarket Notification
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, Indiana 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
DESIGN: 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = IOQ and Original Applicant = HILL-ROM, INC.
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