Affinity Four Birthing Bed, Product Usage: Product is intended to be used as birthing beds for women of child bearing ag
FDA device recall Z-2562-2014 · posted 2014-09-01 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- The attachment latch mechanism can become bent depending on user handling. Latch mechanism bending could lead to improper engagement of the foot section and this could result in injury to the user due to a fall.
- Action taken
- Hill-rom issued an Urgent Field Safety Notice letter dated June 26, 2014 to affected customers. The Notification identified the affected product issue and instructions for product inspection. The letter states that the firm is working on making changes to the Lift-Off foot section that will mitigate risk even if damage was to occur. If you have any questions concerning the notice or requested procedure, please contact Hill-Rom Technical Support at 800-445-3720.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KNC
- Quantity affected
- 13,000 units
- Distribution
- Worldwide Distribution - US Nationwide and the following countries: Argentina , Aruba, Australia, Austria, Bahamas, Bahrain, Belgium, Belize, Bermuda, Brazil, Brunei, Bulgaria, Cayman Islands, Chile,
- Date initiated
- 2014-06-26
- Date posted
- 2014-09-01
- Date terminated
- 2017-07-14
- 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 |