Recall Z-1903-2009 ยท INX Bed, Air Fluidized
Hill-Rom Manufacturing, Inc.
CLINITRON UP-LIFT" 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.
| Date | Aug 25, 2009 (initiated Jun 24, 2009) |
| Status | Terminated |
| Reason | Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed. |
| Root cause | Equipment maintenance |
| 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. |
| Quantity | 625 units (total both units) |
| Distribution | Worldwide Distribution -- United States, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K920112 | CLINITRON C-II Support Systems Intl., Jan 24, 1992 |