Z-0057-04

Clinitron At Home Air Fluidized Therapy Unit

Name: Z-0057-04 Clinitron At Home Air Fluidized Therapy Unit
Creator: Hill-Rom Manufacturing, Inc.
Published: 2002-01-14
License: https://open.fda.gov/license/

Hill-Rom Manufacturing, Inc. / initiated 2002-01-14 / Terminated

FDA source

Hill-Rom Manufacturing, Inc. began a recall of Clinitron At Home Air Fluidized Therapy Unit on 2002-01-14. The reason FDA records is "Power cord overheating". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0057-04
Status: Terminated
Initiated: 2002-01-14
Posted: 2003-10-24
Terminated: 2003-10-27
Recalling firm: Hill-Rom Manufacturing, Inc.
Product: Clinitron At Home Air Fluidized Therapy Unit
Product code: INX Bed, Air Fluidized
Reason for recall: Power cord overheating
FDA 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 in commerce: 1703 units
Distribution: Hill Rom primarily leases these units to home care patients and some are sold nationwide.
Product codes and lots: Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184

Product code INX

K942184Class IIClinitron at Home Air Fluided TherapySsi Medical Services, Inc. / cleared 1995-02-07

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)