Z-0457-2011

Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA

Name: Z-0457-2011 Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA
Creator: Respironics California Inc
Published: 2010-07-02
License: https://open.fda.gov/license/

Respironics, Inc. / initiated 2010-07-02 / Terminated / root cause: design

FDA source

Respironics California Inc began a recall of Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA on 2010-07-02. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0457-2011
Status: Terminated
Initiated: 2010-07-02
Posted: 2010-11-24
Terminated: 2010-12-01
Recalling firm: Respironics, Inc.
Product: Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
Product code: MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: 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

Product code MNT

K082660Class IIV60 Ventilator, Model V8000Respironics California, Inc. / cleared 2009-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)