Recall Z-2168-2010
Hill-Rom, Inc. · initiated September 16, 2009
Product
Hill-Rom 405 Bed, P1440B, (electric) Hill Rom Batesville, IN. Intended for low to moderate acuity patients in the low end acute care area of the hospital.
Codes / lots: K110HE1421, K110HE1422, K110HE1423, K110HE1424, K110HE1425, K110HE1426, K110HE1427, K110HE1428, K110HE1429, K110HE1430, K110HE1431, K110HE1432, K110HE1433, K110HE1434, K110HE1435, K110HE1436, K110HE1437, K110HE1438, K110HE1439, K110HE1440, K110HE1441, K110HE1442, K110HE1443, K110HE1444, K110HE1445, K110HE1446, K110HE1447, K110HE1448, K110HE1449, K110HE1450, K110HE1451, K110HE1452, K110HE1453, K110HE1454, K110HE1455, K110HE1456, K110HE1457, K110HE1458, K110HE1459, K110HE1460, K110HE1461, K110HE1462, K110HE1463, K110HE1464, K110HE1465, K110HE1466, K110HE1467, K110HE1468, K110HE1469, K110HE1470, K110HE1471, K110HE1472, K110HE1473, K110HE1474, J145HE0493, J144HE0452, J144HE0462, J144HE0469, J144HE0472, J145HE0476, J145HE0479, J145HE0480, J145HE0487, J145HE0488, J145HE0495, J145HE0475, J144HE0454, J144HE0455, J144HE0457, J144HE0470, J144HE0471, J145HE0474, J145HE0477, J145HE0489, J145HE0490, J145HE0494, K040HE0576, K040HE0577, K040HE0579, K040HE0580, K040HE0581, K04HE0578, J194HE0770, J194HE0771, J194HE0772, J194HE0773, J194HE0774, J194HE0775, J194HE0776, J194HE0777, J194HE0778, J194HE0779, J194HE0780, J194HE0781, J194HE0782, J194HE0783, J194HE0784, J194HE0785, J194HE0786, J194HE0787…
Reason for recall
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.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-2168-2010
- Initiated
- September 16, 2009
- Posted by FDA
- August 3, 2010
- Terminated
- March 16, 2012
- Product code
- FNL – Bed, Ac-Powered Adjustable Hospital
- Quantity
- 2,973 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, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia…
- Recalling firm
- Hill-Rom, Inc., Batesville, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2167-2010 | Hill-Rom 305 Bed, P1441B - Non electric, Hill Rom Batesville, IN. Intended for low to…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |
| Z-2169-2010 | Hill-Rom Basic Care Bed, P1440A (Electric), Hill Rom Batesville, IN. Intended for low to…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |
| Z-2170-2010 | Hill-Rom Basic Care Bed, P1441A (Non-electric), Hill Rom Batesville, IN. Intended for…The flexing of the junction of the sleep deck's head and mid sections can create excess pressure on the… | 09/16/2009Terminated |