FDA Device

Clinitron At Home Air Fluidized Therapy Unit

Hazard

Power cord overheating

What You Should Do

Remedy

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.

Products

Clinitron At Home Air Fluidized Therapy Unit
Brand
Hill-Rom Manufacturing, Inc.
UPC
Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184

Units Affected

1703 units