CLINITRON CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure.
FDA Recall Z-1902-2009 · Posted 2009-08-25
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Recalling FirmHill-Rom Manufacturing, Inc.
Recall StatusTerminated
Product CodeINX
Date Initiated2009-06-24
Date Terminated2012-07-11
Product Quantity625 units (total both units)
Reason for Recall
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
Firm Action
Hill-Rom issued an "Urgent Field Safety Notice" letter dated February 2, 2009 addressed to Facility Risk Managers and Facility Administrators. The notice detailed the issue and instructed users on actions to be taken.
For further information, please contact Hill-Rom Customer Service at 1-800-638-2546.
Root Cause
Equipment maintenance
Distribution Pattern
Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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