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Terminated

Clinitron At Home Air Fluidized Therapy Unit

FDA Recall Z-0057-04 · Posted 2003-10-24

Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeINX
Date Initiated2002-01-14
Date Terminated2003-10-27
Product Quantity1703 units

Reason for Recall

Power cord overheating

Firm 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.

Root Cause

Other

Distribution Pattern

Hill Rom primarily leases these units to home care patients and some are sold nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K942184CLINITRON AT HOME AIR FLUIDED THERAPYSsi Medical Services, Inc. · 1995-02-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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