FDA Medical Device Recalls (openFDA)
Hill-Rom Manufacturing, Inc.: CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
- Recall number
- Z-1903-2009
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Product
- CLINITRON UP-LIFT" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
- Status
- Terminated
- Initiated
- 2009-06-24
- Posted
- 2009-08-25
- Terminated
- 2012-07-11
- Reason
- Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
- Root cause
- Equipment maintenance
- Action
- Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken. For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
- Quantity
- 625 units (total both units)
- Distribution
- Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K920112"]
- PMA numbers
- not on file
- Product code
- INX
- Firm FEI
- 1045510
- Firm city
- Charleston
- Firm state
- SC
- 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