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U.S. Department of Health and Human Services

Class 2 Device Recall Power Bariatric Recliner

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 Class 2 Device Recall Power Bariatric Reclinersee related information
Date Initiated by FirmJanuary 20, 2016
Date PostedFebruary 23, 2016
Recall Status1 Terminated 3 on February 07, 2017
Recall NumberZ-0860-2016
Recall Event ID 73138
Product Classification Chair, geriatric - Product Code FRJ
ProductHill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort.
Code Information Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range:  L341RW9151 through P070RW0812 
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information ContactHill-Rom Technical Support
800-445-3720
Manufacturer Reason
for Recall		The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.
FDA Determined
Cause 2		Under Investigation by firm
ActionHill-Rom sent an Urgent Field Safety Notice by POD (Proof of Delivery) mailing on January 20, 2016, to all affected customers.. The notice identified the product, the problem, and the action to be taken by the customer. Customers willl be contacted for appointments to update the power chairs with missing linkage side shields. Hill-Rom will be installing the missing linkage side shields to the Hill-Rom P9096 Power Bariatric Recliner to address this issue. Customers were instructed to ensure patients and others do not insert an appendage into the foot rest linkage mechanism during opening or closing. Customers may contact Hill-Rom Technical Support at 800-445-3720, if they have any questions.
Quantity in Commerce216
DistributionWorldwide Distribution - US including AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI, WV, WY, VA Medical Center and Internationally to Canada and Mexico. **Consumer Recommended Depth - Consumers/User**
Total Product Life CycleTPLC 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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