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U.S. Department of Health and Human Services

Class 2 Device Recall Respironics V60 Ventilator

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  Class 2 Device Recall Respironics V60 Ventilator see related information
Date Initiated by Firm July 02, 2010
Date Posted November 24, 2010
Recall Status1 Terminated 3 on December 01, 2010
Recall Number Z-0457-2011
Recall Event ID 56147
510(K)Number K082660  
Product Classification Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
Product Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
Code Information Serial Numbers: SS093803N, 100013661, 100009972, 100010387, 100010388, 100009963, SS093901A, SS093901E, SS0939033, 100009502, 100009676, 100009818, 100009815, 100009909, 100009813, SS093903A, SS093904Z, SS093902N, SS093901W, SS0939027, SS093902J, SS0939046, SS093904N, 100003864, 100009411, SS0938074, 100010234, 100009735, 100009002, 100010019, 100009967, 100010060, 100010101, 100013675, 100009858, 100011301, 100012282, SS0938075, 100009124, 100004133, 100009499, 100011303, 100009563, 100009852, 100009913, SS093800V, SS093802M, SS093802R, SS093805R, 100009917, 100012696, 100004549, SS0938017, 100009665, 100009341, 100009094, 100009765, 100009328, 100012706, 100010204, 100009088, 100010389, 100009667, 100009414, SS093901K, 100013477, 100009087, 100009960, SS093802D, 100009675, 100009004, 100010311, 100010406, SS093801E, 100011744, 100009817, 100009669, 100010052, 100010015, 100010065, 100010386, 100009968, 100009962, 100009941, 100011800, 100009939, 201000202, 100009761, 100009762, 100009679, 100012262, SS093901C, 100010515, 100010231, SS0938026, 100009732, 100012264, 100003665, 100009816, 100009854, 100012769, 100009329, 100009097, 100009856, 100009566, 100009501, 100011308, 100011343, 100010160, SS093806S, 100009424, 100010408, 100009125, 100008995, 100009415, 100009326, 100009674, 100009730, 100010054, 100010512, 100009859, 100009961, 100009971, 100009934, 100009964, 100010016, 100010017, 100010100, 100010383, 100010401, 100010403, 100010510, 100009670, 100010164, 100010057, 100010139, 100009729, 100009731, 100010316, 100009091, 100009671, 100009767, 100009811, 100010018, 100011330, 100011334, 100009734, 100009810, 100009766, 100009938, 100011268, 100011272, 100009943, 100010058, 100010317, 100010384, 100010391, 100010402, 100010511, 100009763, SS0939050, 100009428, 100009423, 100012464, 100010243, 100010518, 100010230, 100009427, 100010315, 100010509, 100010407, 100010504, 100010507, 100010506, 100011339, 100011302, SS093805C, 100009850, 100011329, 100009422, 100003911, 201000493, 100009565, 100009937, 100011269, 100011307, 100009977, 100009936, SS093802P, 100009819, 100009664, 100011263, 100011325, 100010390, 100010519, 100008996, 100010162, 100008799, 100009416, 100009413, 100009005, 100012545, 100009090, 100009092, 100010014, 100009430, 100009412, 100009345, 100009851, 100015074, 100009342, 100009661, 100009337, 100009668, 100009966, 100009247, 100010410, 100010405, 100010409, 100010314, 100010503, 100010505, 100009733, SS093904P, 100011337, 100009673, 100011336, 100011309, 100011338, 100011340, 100009420, 100009672, 100009666, 100009245, 100009419, 100009418, 100009340, 100009332, 100003668, 100008998, 100011306, 100009855, 100008790, 100011341, 100011326, 100011265, 100011335, 100010272, SS0938071, SS0938042, 100014139, 100009662, 100010209, 100010241, 100010240, 100010244, 100010064, 100010270, 100010277, 100010278, 100010309, 100010310, 100009085, 100009678, 100009764, SS093806B, 100009814, 100009677, 100011328, 100011266, 100011270, 100011267, SS093800Y, SS093806W, 100009857, 100010404, SS0938036, 100008797, 100012765, 100012762, 100012654, 100003683, 100009975, 100010313, 100010279, 100010308, 100009264, 100009327, 100009335, 100009812, 100012775, 100010508, 100009970, 100010166, 100010312, 100010513, 100009003, 100009912, 100009916, 100009343, 100010520, 100011271, 100011300, 100010385, 100010382, 100009093, 100012658, 100009246, 100009429, 100009089, 100008796, 100010275, 100012648, 100009330, 100009120, 100010517, 100012267, 100012265, 100011331, 100011342, 100010276, 100009122, 100008795, 100008798, 100009096, 100009338, 100009001, 100009098, 100012652, 100012661, 100012166, 100012690. 100009853, 100009931, 100011264, 100011333, 100011327, 100005394, 100009123, 100009344, 100008997, 100009932, 100009000, 100008999, 100004130, 100009564, 100009086, 100011304, 100010514, 100010274, 100010516, 100010169, 100008437
Recalling Firm/
Manufacturer		 Respironics California Inc
2271 Cosmos Ct
Carlsbad CA 92011
For Additional Information Contact
760-918-7300
Manufacturer Reason
for Recall		 Respironics California Inc has received customer complaints of an odor or burning smell coming from the V60 Ventilator, and identified a component on the Power Management PCB that exhibited thermal damage.
FDA Determined
Cause 2		 Device Design
Action Phililps Healthcare issued an Urgent Medical Device Field Correction letter dated July 2, 2010 concerning the RespironicsV60 Ventilator issue. Customers will be contacted by US Field Service Technicians and international distributors to schedule and perform inspections and replacement of the affected component. The unit may continue to be used pending completion of the field inspection. Customers may contact Respironics US Customer Service about this action at 1 800 345 6443, option #5, then option #1.
Quantity in Commerce 504
Distribution Worldwide Distribution: Throughout the US and Puerto Rico,, and to the countries of: Australia, Austria, Belgium, Canada, Denmark, France, Germany, Hong Kong, India, Italy, Kenya, Kuwait, Libya, Malaysia, Oman, Netherlands, Norway, the United Kingdom, Saudi Arabia, and Spain.
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.
510(K) Database 510(K)s with Product Code = MNT and Original Applicant = RESPIRONICS CALIFORNIA, INC.
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