Recall Z-0057-04 ยท INX Bed, Air Fluidized
Hill-Rom Manufacturing, Inc.
Clinitron At Home Air Fluidized Therapy Unit
| Date | Oct 24, 2003 (initiated Jan 14, 2002) |
| Status | Terminated |
| Reason | Power cord overheating |
| Root cause | Other |
| 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 |
| Quantity | 1703 units |
| Distribution | Hill Rom primarily leases these units to home care patients and some are sold nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942184 | CLINITRON AT HOME AIR FLUIDED THERAPY Ssi Medical Services, Inc., Feb 7, 1995 |