FDA Medical Device Recalls (openFDA)
Hill-Rom Manufacturing, Inc.: Clinitron At Home Air Fluidized Therapy Unit
- Recall number
- Z-0057-04
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Product
- Clinitron At Home Air Fluidized Therapy Unit
- Status
- Terminated
- Initiated
- 2002-01-14
- Posted
- 2003-10-24
- Terminated
- 2003-10-27
- Reason
- Power cord overheating
- Root cause
- Other
- Action
- Consignees were notified by letter sent January 14, 2002 warning them of the hazard involved with the defective part. They were informed that Hill Rom needed to replace the power cord on each unit to correct the possibility of the power cord from overheating, melting or smoking. The maintenance would be performed at the location of each unit (most of which are at their rental facilities located nationwide) by the firm''s servicing representatives. Meanwhile, customers were urged to check the power cord to ensure that it is fully inserted into the wall outlet and the connector on the Clinitron At Home Air Fluidized Therapy Unit. The modification was to be completed by August 31, 2002.
- Quantity
- 1703 units
- Distribution
- Hill Rom primarily leases these units to home care patients and some are sold nationwide.
- Lot, serial or model codes
- Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184
- 510(k) numbers
- ["K942184"]
- 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