Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0860-2016Class II

Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was...

Hill-Rom Inc. / initiated 2016-01-20 / Terminated

Hill-Rom, Inc. began a recall of Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design... on . FDA classified it as Class II and gives the reason as "The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0860-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Hill-Rom Inc.
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.
Product code
FRJ Chair, Geriatric
Reason for recall
The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury.
FDA root cause
Under Investigation by firm
Action
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.
Quantity in commerce
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**
Product codes and 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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0860-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0860-2016Class IITerminatedVoluntary: Firm initiated