Hill-Rom brand Affinity three birthing bed
FDA device recall Z-0902-03 · posted 2003-05-29 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- Possible electrical shock hazard, as the power cord grounding pin may break off or become detached.
- Action taken
- Letters dated April 24, 2003 were sent to each consignee instructing them to inspect the beds for power cords with non-flared ground pins, to cut plug off any such cords when found, and replace these plugs with new plugs with the flared ground pin. [The type of plug on the unit can be seen by the naked eye, as the plug is transparent plastic molding.]
- Root cause
- Other
- Status
- Terminated
- Product code
- KNC
- Distribution
- United States, Bahamas, Bermuda, Canada, Colombia, Costa Rica, Dominican Republic, Guam, Japan, Mexico, Panama, Saudi Arabia, South Korea, Taiwan and Venezuela
- Date initiated
- 2003-04-24
- Date posted
- 2003-05-29
- Date terminated
- 2003-09-25
- Location
- Batesville, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFINITY BED MODEL 3600 SERIES (K915779) | Hill-Rom, Inc. | 1993-02-24 |