Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006
FDA device recall Z-0617-2008 · posted 2008-04-02 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- Brake failure: The brakes may not hold or lock properly.
- Action taken
- Hill-Rom notified consignees via Urgent Medical Device Correction letter dated 9/6/07. The letter instructed facilities to continue using the beds if they pass a test of the brake mechanism; and a Hill-Rom representative will contact the facility to schedule a replacement of the detent mechanism and adjustment of the casters.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- HDD
- Quantity affected
- 1,796
- Distribution
- Worldwide Distribution - USA, Argentina, Australia, Bahamas, Belgium, Belize, Brazil, Canada, China, Denmark, Dominican Republic, France, Germany, Guam, Hong Kong, India, Indonesia, Ireland, Israel, I
- Date initiated
- 2007-09-06
- Date posted
- 2008-04-02
- Date terminated
- 2010-10-15
- 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 |