Hill-Rom Affinity Four Birthing Bed, Hill-Rom Company, Inc., Batesville, Indiana; Model P3700B. Intended to be used as b
FDA device recall Z-0548-2010 · posted 2009-12-17 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- The brakes may not hold or lock.
- Action taken
- Hill-Rom issued an "Urgent Safety Notice" notification dated November 16, 2009 to customers. The letter advised users of the problem and asking them to locate the beds and to remove them from use until corrected if possible and, if not possible to inspect them for the problem and remove them from use if it is present. The firm will visit each account to make corrections. For further information, contact Hill-Rom Technical Support at 1-800-445-3720.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HDD
- Quantity affected
- 2551 (US), 4171 (OUS)
- Distribution
- Worldwide Distribution -- United States, Canada, Argentina, Australia, Bahamas, Brazil, Chile, China, Denmark, Dominican Republic, France, Great Britain, Hong Kong, India, Indonesia, Ireland, Israel,
- Date initiated
- 2009-11-16
- Date posted
- 2009-12-17
- Date terminated
- 2012-07-02
- Location
- Batesville, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFINITY BED MODEL 3600 SERIES (K915779) | Hill-Rom, Inc. | 1993-02-24 |