FDA Medical Device Recalls (openFDA)
Hill-Rom, Inc.: Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
- Recall number
- Z-1864-2012
- Recalling firm
- Hill-Rom, Inc.
- Product
- Advanta 2 Bed. The Advanta 2 Bed is intended for low to moderate acuity patients in the medical/surgical area of the hospital.
- Status
- Terminated
- Initiated
- 2012-06-18
- Posted
- 2012-06-22
- Terminated
- 2014-06-06
- Reason
- During an evaluation of Advanta 2 siderail samples returned from the field it was found that the screws used to attach the siderail were being stripped from the plastic cavity of the siderail.
- Root cause
- Process design
- Action
- Hill-Rom sent an "URGENT FIELD SAFETY NOTICE" dated May 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included a Customer Response Form for customers to complete and return to the firm. Contact Hill-Rom Technical Support at 800-445-3720 for questions regarding this notice.
- Quantity
- 7843 devices
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, France, and Singapore.
- Lot, serial or model codes
- AdvantaTM 2 beds (P1190) produced between August 10, 2009 and October 6, 2011; bed S/N between K222AT9180 and M279AT4403
- 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