Recall Z-2170-2010 ยท FNJ Bed, Manual
Hill-Rom, Inc.
Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
| Date | Aug 3, 2010 (initiated Sep 16, 2009) |
| Status | Terminated |
| Reason | The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the pivot pin E-ring, which could cause the E-ring to come off. |
| Root cause | Device Design |
| Action | The firm sent an Urgent Field Safety Notice to its customers dated 9/16/2009. The letter identified the affected product, explained the reason for the recall, actions to be taken, and a contact reference. Customers are to locate the affected product, examine the pivot points and ensure the E-ring is present. If the E-ring is missing, then the affected bed is to be taken out of service. Customers' distributors or agents will contact them with a permanent fix. Questions should be directed towards Hill-Rom Technical Support. |
| Quantity | 962 beds |
| Distribution | Worldwide Distribution -- Argentina, Bahrain, Bhutan, Brazil, Bulgaria, Chili, China, Columbia, Costa Rica, Ecuador, Egypt, Eritrea, France, Hong Kong, India, Indonesia, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Malaysia, Mexico, Morocco, Oman, Pakistan, Palestine, Panama, Papua New Guinea, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.