Recall Z-0860-2016

Hill-Rom, Inc. · initiated January 20, 2016

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Hill-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.

Codes / lots: 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

Reason for recall

The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.

FDA-determined cause: Under Investigation by firm

Action taken

Hill-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.

Details

Recall number
Z-0860-2016
Initiated
January 20, 2016
Posted by FDA
February 23, 2016
Terminated
February 7, 2017
Product code
FRJ – Chair, Geriatric
Quantity
216
Distribution
Worldwide 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**
Recalling firm
Hill-Rom, Inc., Batesville, IN

Official FDA recall record