FDA Medical Device Recalls (openFDA)
Hill-Rom, Inc.: 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.
- Recall number
- Z-0332-2011
- 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.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-11-09
- Terminated
- 2014-10-06
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- XL100092, XL100091, XL100077, XL100124 and XL101363.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FNL
- Firm FEI
- 1824206
- Firm city
- Batesville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28