Hill-Rom Affinity Three Birthing Bed, Model P3700.
FDA device recall Z-1503-06 · posted 2006-09-14 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- The cable on the auxiliary outlet may become pinched, which may result in an electrical short with melting of the plastic transformer and the emission of smoke.
- Action taken
- Customers were notified via letter dated 8/18/06 and instructed to either correct the problem themselves with the instructions provided or to contact the firm requesting a visit from the recalling firm to correct their beds.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNC
- Quantity affected
- 9,324
- Distribution
- Nationwide, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, France, French Polynesia, Germany, Guam, Hong Kong, Iceland, India, Indonesia
- Date initiated
- 2006-08-18
- Date posted
- 2006-09-14
- Date terminated
- 2009-07-14
- 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 |