Class 2 Device Recall HillRom Basic Care Bed

• Date Initiated by Firm: September 16, 2009
• Date Posted: August 03, 2010
• Recall Status: Terminated on March 16, 2012
• Recall Number: Z-2170-2010
• Recall Event ID: 56018
• Product Classification: Manual Bed - Product Code FNJ
• Product: 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.
• Code Information: J343BE4440, J343BE4441, J343BE4442, J343BE4443, J343BE4444, J343BE4445, J343BE4446, J343BE4447, J343BE4448, J343BE4449, J343BE4450, J343BE4451, J343BE4452, J343BE4453, J343BE4454, J343BE4455, J343BE4456, J343BE4457, K092BM1266, K092BM1267, K092BM1268, K092BM1269, K092BM1270, K092BM1271, K092BM1272, K092BM1273, K092BM1299, K092BM1300, K092BM1301, K092BM1302, K092BM1303, K092BM1304, K092BM1305, K092BM1306, K092BM1307, K093BM1308, K093BM1309, K093BM1310, K093BM1311, K093BM1312, K093BM1313, K093BM1314, K093BM1315, K093BM1316, K093BM1317, K093BM1318, K093BM1319, K093BM1320, K093BM1321, J233BM2121, J233BM2122, J233BM2123, J233BM2124, J233BM2125, J233BM2126, J233BM2127, J233BM2128, J233BM2129, J233BM2130, J233BM2131, J233BM2132, J233BM2133, J233BM2134, J233BM2135, J233BM2136, J233BM2137, J233BM2138, J233BM2139, J233BM2140, J233BM2141, J233BM2142, J233BM2143, J233BM2144, J233BM2145, J233BM2146, J233BM2147, J233BM2148, J233BM2149, J233BM2150, J233BM2151, J233BM2152, 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J322BM4107, J322BM4108, J322BM4109, K040BM0535, K040BM0536, K040BM0537, K040BM0538, K040BM0539, K041BM0540, K041BM0541, K041BM0542, K041BM0543, K041BM0544, K041BM0545, K041BM0546, K041BM0547, K041BM0548, K041BM0549, K041BM0550, K041BM0551, K041BM0552, K041BM0553, K041BM0554, K041BM0555, K041BM0556, K041BM0557, K041BM0558, K041BM0559, K041BM0560, K041BM0561, K041BM0562, K041BM0563, K041BM0564, K041BM0565, K041BM0566, K041BM0567, K041BM0568, K041BM0569, K041BM0570, K041BM0571, K041BM0572, K041BM0573, K041BM0574, K041BM0575, K041BM0576, K041BM0577, K041BM0578, K041BM0579, K041BM0580, K041BM0581, K041BM0582, K041BM0583, K041BM0584, K041BM0585, K041BM0586, K041BM0587, K041BM0588, K041BM0589, K042BM0590, K042BM0591, K042BM0592, K042BM0593, K042BM0594, K042BM0595, K042BM0596, K042BM0597, K042BM0598, K042BM0599, K042BM0600, K042BM0601, K042BM0602, K042BM0603, K042BM0604, K042BM0605, K042BM0606, K042BM0607, K042BM0608, K042BM0609, K042BM0610, K042BM0611, K042BM0612, K042BM0613, K042BM0614, 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K044BM0698, K044BM0699, K044BM0700, K044BM0701, K044BM0702, K044BM0703, K044BM0704, K044BM0705, K044BM0706, K044BM0707, K044BM0708, K044BM0709, K044BM0710, K044BM0711, K044BM0712, K044BM0713, K044BM0714, K044BM0715, K044BM0716, K044BM0717, K044BM0718, K044BM0719, K044BM0720, K044BM0721, K044BM0722, K044BM0723, K044BM0724, K044BM0725, K044BM0726, K044BM0727, K044BM0728, K044BM0729, K044BM0730, K044BM0731, K044BM0732, K044BM0733, K044BM0734, K044BM0735, K044BM0736, K044BM0737, K044BM0738, K044BM0739, K045BM0740, K045BM0741, K045BM0742, K045BM0743, K045BM0744, K009BM0091, J355BM4754, J355BM4755, J355BM4756, J355BM4757, J355BM4758, J355BM4759, J355BM4760, J355BM4761, J355BM4762, J355BM4763, J355BM4764, J355BM4765, J355BM4766, J355BM4767, J355BM4768, J355BM4769, J355BM4770, J355BM4771, J355BM4772, J355BM4773, J355BM4774, J355BM4775, J355BM4776, J355BM4777, J355BM4778, J355BM4779, J355BM4780, J355BM4781, J355BM4782, J355BM4783, J355BM4784, J355BM4785, J355BM4786, J355BM4787, J355BM4788, J355BM4789, K009BM0092, K009BM0093, K009BM0094, K009BM0095, K009BM0096, K009BM0097, K009BM0098, K009BM0099, K009BM0100, K009BM0101, K009BM0102, K009BM0103, K009BM0104, K009BM0105, K009BM0106, K009BM0107, K009BM0108, K009BM0109, K009BM0110, K009BM0111, K009BM0112, K009BM0113, K009BM0114, K009BM0115, K009BM0116, K009BM0117, K009BM0118, K009BM0119, K009BM0120, K009BM0121, K010BM0122, K010BM0123, K010BM0124, K010BM0125, K010BM0126, K010BM0127, K010BM0128, K010BM0129, K010BM0130, K010BM0131, K010BM0132, K010BM0133, K010BM0134, K010BM0135, K010BM0136, K010BM0137, K010BM0138, K010BM0139, K010BM0140, K010BM0141, K010BM0142, K010BM0143, K010BM0144, K010BM0145, K010BM0146, K010BM0147, K010BM0148, K010BM0149, K010BM0150, K010BM0151, K010BM0152, K010BM0153, K010BM0154, K010BM0155, K010BM0156, K010BM0157, K010BM0158, K010BM0159, K010BM0160, K010BM0161, K010BM0162, K010BM0163, K010BM0164, K010BM0165, K010BM0166, K010BM0167, K010BM0168, K010BM0169, K010BM0170, K010BM0171, K011BM0172, K011BM0173, 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• Recalling Firm/ Manufacturer: Hill-Rom, Inc.; 125 E Pearl St; 1069 State Route 46 East; Batesville IN 47006
• For Additional Information Contact: 812-934-7777
• Manufacturer 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: 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 in Commerce: 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, Paraguay, Peru, Philippines, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Syria, Taiwan, Thailand, Trinidad & Tobago, Turkey, United Arab Emirates, United States, Uruguay, Venezuela, and Vietnam.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.