Clinitron At Home Air Fluidized Therapy Unit
FDA device recall Z-0057-04 · posted 2003-10-24 · Terminated
Recall details
- Recalling firm
- Hill-Rom Manufacturing, Inc.
- Reason for recall
- Power cord overheating
- Action taken
- 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
- Status
- Terminated
- Product code
- INX
- Quantity affected
- 1703 units
- Distribution
- Hill Rom primarily leases these units to home care patients and some are sold nationwide.
- Date initiated
- 2002-01-14
- Date posted
- 2003-10-24
- Date terminated
- 2003-10-27
- Location
- Charleston, SC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLINITRON AT HOME AIR FLUIDED THERAPY (K942184) | Ssi Medical Services, Inc. | 1995-02-07 |