Recall Z-2268-2010 ยท FNL Bed, Ac-Powered Adjustable Hospital
Hill-Rom, Inc.
Hill-Rom 1000 bed model P1160.
| Date | Aug 24, 2010 (initiated Apr 13, 2009) |
| Status | Terminated |
| Reason | Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed. |
| Root cause | Device Design |
| Action | Hill-Rom sent a customer notification letter dated 4/9/2009. A second notice was sent to all customers on 7/9/2009. The letter included instructions and a Customer Response Form, along with the required parts. Customers were instructed to do the correction on their affected beds and return the completed customer response form within 45 days. |
| Quantity | 39,971 both products |
| Distribution | Worldwide distribution: USA, Afghanistan, Algeria, American Samoa, Argentina, Australia, Bermuda, Brazil, Canada, Chili, China, Colombia, Costa Rica, Cuba, Ecuador, Egypt, Hong Kong, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Kyrgyzstan, Lebanon, Libya, Malaysia, Mexico, Oman, Panama, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.