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U.S. Department of Health and Human Services

Class 2 Device Recall Excel Care Bariatric Bed

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  Class 2 Device Recall Excel Care Bariatric Bed see related information
Date Initiated by Firm March 05, 2010
Date Posted November 09, 2010
Recall Status1 Terminated 3 on October 06, 2014
Recall Number Z-0332-2011
Recall Event ID 55301
Product Classification Bed, ac-powered adjustable hospital - Product Code FNL
Product Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN.

Intended Use: The Excel Care Bariatric Bed is for bariatric patients with varying medical and physical conditions. The bed supports patients between 250 and 1000 pounds.
Code Information XL100092, XL100091, XL100077, XL100124 and XL101363. 
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
125 E Pearl St
1069 State Route 46 East
Batesville IN 47006
For Additional Information Contact
812-934-7777
Manufacturer Reason
for Recall		 The firm received complaints regarding the siderails not operating correctly or becoming inoperable. The siderails could experience false latching, unintentional lowering or become inoperable. There have been reports of 5 patient falls and 2 injuries to caregivers.
FDA Determined
Cause 2		 Device Design
Action Hill-Rom sent out "Urgent Medical Device Correction" letters dated March 5, 2010. The letters described the product, problem and actions to be taken by the customers. The letters instructed the customers to locate the beds and examine the siderails for any visible damage (cracks, bending, loose parts) and conduct a physical assessment of all four siderails on each bed to determine if the sideral could be placed in all positions. If the siderails were found to be inoperable, the bed was to be taken out of service until a qualified Hill-Rom technician can make any necessary correction. The customers were instructed to contact Hill-Rom to make arrangements and inform them of all beds that they have loaned, sold, no longer use or disposed of at 800-445-3720, option 2. The letter states the firm is evaluating a design change to the siderail. If you have any questions concerning this request or the procedure as outlined, please contact Hill-Rom Technical Support at 800-445-3720, option 2.
Quantity in Commerce 1,406 beds both models.
Distribution Worldwide distribution: USA states including: AK, FL, HI, IN, KS, LA, MS, OK, PA, TN, VT, and WA and countries including: Canada, Mexico, Angola, Australia, Saudi Arabia, Qatar, and United Emirates.
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.
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