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U.S. Department of Health and Human Services

Class 2 Device Recall Clinitron At Home Air Fluidized Therapy Unit

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 Class 2 Device Recall Clinitron At Home Air Fluidized Therapy Unitsee related information
Date Initiated by FirmJanuary 14, 2002
Date PostedOctober 24, 2003
Recall Status1 Terminated 3 on October 27, 2003
Recall NumberZ-0057-04
Recall Event ID 27190
510(K)NumberK942184 
Product Classification Bed, Air Fluidized - Product Code INX
ProductClinitron At Home Air Fluidized Therapy Unit
Code Information Model 206 (CS), Serial numbers 101671 and 103443 510K: K942184 
FEI Number 1045510
Recalling Firm/
Manufacturer		 Hill-Rom Manufacturing, Inc.
4349 Corporate Road
Charleston SC 29405
For Additional Information ContactMark Lanning
843-740-8586
Manufacturer Reason
for Recall		Power cord overheating
FDA Determined
Cause 2		Other
ActionConsignees 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 Commerce1703 units
DistributionHill Rom primarily leases these units to home care patients and some are sold nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = INX
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