Z-0332-2011

Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN

Name: Z-0332-2011 Excel Care Bariatric Bed, P 610A, Hill-Rom, Batesville, IN
Creator: Hill-Rom, Inc.
Published: 2010-03-05
License: https://open.fda.gov/license/

Hill-Rom Inc. / initiated 2010-03-05 / Terminated / root cause: design

FDA source

Hill-Rom, Inc. began a recall of 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... on 2010-03-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0332-2011
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-11-09
Terminated: 2014-10-06
Recalling firm: Hill-Rom Inc.
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.
Product code: FNL Bed, Ac-Powered Adjustable Hospital
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: XL100092, XL100091, XL100077, XL100124 and XL101363.

Product code FNL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)