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U.S. Department of Health and Human Services

Class 2 Device Recall HillRom 100 Bed

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  Class 2 Device Recall HillRom 100 Bed see related information
Date Initiated by Firm April 13, 2009
Date Posted August 24, 2010
Recall Status1 Terminated 3 on June 06, 2011
Recall Number Z-2268-2010
Recall Event ID 55156
Product Classification hospital bed - Product Code FNL
Product Hill-Rom 1000 bed model P1160.
Code Information K029AP6787, K029AP6788, K029AP6790, J317AP5267, J206AP2503, J206AP2506, J206AP2511, J206AP2513, J213AP2581, J220AP2773, J220AP2775, J220AP2777, J220AP2778, J224AP2904, J224AP2906, J224AP2907, J224AP2908, J220AP2770, J224AP2909, J224AP2916, J227AP3052, J227AP3053, K027AP6733, K027AP6735, K027AP6736, K027AP6738, J220AP2772, J220AP2774, J224AP2905, J274AP4108, J274AP4113, J274AP4114, J274AP4134, J274AP4135, J274AP4136, J274AP4102, J350AP5889, J350AP5890, J350AP5891, J350AP5892, J350AP5893, J350AP5894, J350AP5895, J350AP5896, J350AP5897, J350AP5899, J350AP5900, J350AP5901, J350AP5902, J350AP5903, J350AP5904, J350AP5905, J350AP5906, J350AP5907, J350AP5908, J350AP5909, J350AP5998, J352AP5988, J352AP5989, J352AP5990, J352AP5991, J352AP5992, J352AP5993, J352AP5994, J352AP5995, J352AP5996, J352AP5997, J352AP5998, J352AP5999, J352AP6000, J352AP6001, J352AP6002, J352AP6003, J352AP6004, J352AP6005, J352AP6006, J352AP6007, J352AP6008, J352AP6009, J352AP6010, J352AP6011, J352AP6012, K020AP6555, K020AP6556, K020AP6557, K020AP6558, K020AP6559, K020AP6560, J354AP6044, J354AP6045, J354AP6046, J354AP6047, J354AP6048, J354AP6049, J354AP6050, J354AP6051, J354AP6052, J354AP6053, J354AP6054, J354AP6056, J354AP6057, J354AP6058, J354AP6059, J354AP6042, J354AP6043, J274AP4103, J274AP4105, J274AP4106, J274AP4107, J274AP4109, J274AP4110, J274AP4111, J274AP4115, J274AP4117, J274AP4118, J274AP4120, J274AP4125, J274AP4127, J274AP4129, J274AP4132, J274AP4137, J274AP4138, J282AP4359, J282AP4365, J282AP4366, J324AP5383, J324AP5384, J324AP5385, J324AP5386, K027AP6720, K027AP6723, K027AP6726, K027AP6727, K027AP6728, K027AP6729, K027AP6730, K027AP6731, K027AP6732, K027AP6734, K027AP6737, K027AP6739, K027AP6740, K027AP6741, K027AP6742, K028AP6773, K028AP6774, K038AP6999, K038AP7000, K038AP7001, K038AP7002, J274AP4099, J274AP4100, J274AP4112, J274AP4116, J274AP4119, J274AP4122, J274AP4126, J274AP4131, J206AP2509, J213AP2580, J220AP2764, J220AP2767, J227AP3035, J227AP3036, J227AP3037, J227AP3039, J227AP3040, J227AP3041, J227AP3042, J227AP3043, J227AP3044, J227AP3045, J227AP3046, J227AP3047, J227AP3048, J227AP3049, J227AP3051, J206AP2508, J206AP2512, J213AP2578, J213AP2579, J206AP2505, J220AP2761, J220AP2762, J220AP2763, J220AP2765, J220AP2766, J220AP2768, J220AP2769, J227AP3038, J274AP4097, J274AP4098, J274AP4104, J274AP4128, J274AP4130, J274AP4133, K006AP6220, K006AP6221, J309AP4986, J309AP4987, J309AP4988, J309AP4989, J309AP4990, J309AP4991, J143AP0940, J143AP0941, J143AP0937, J143AP0944, J143AP0943, J220AP2788, J220AP2789, J274AP4121, J206AP2504, J206AP2507, J206AP2510, J206AP2514, J240AP3514, J317AP5268, J317AP5269, J143AP0945, J143AP0946, J220AP2771, J220AP2776, J220AP2779, J220AP2780, J220AP2781, J220AP2790, J220AP2791, J220AP2792, J227AP3054, J227AP3055, J227AP3056, J239AP3425, J239AP3426, J239AP3428, J239AP3429, J239AP3430, J239AP3431, J239AP3432, J143AP0939, J354AP6055 and J303AP4873.
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		 Pinch hazard. Potential for shearing action between the side rail arm and the bracket used to secure the side rail to the bed.
FDA Determined
Cause 2		 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 in Commerce 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, Paraguay, Philippines, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Syria, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Yemen.
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.
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