Events

Recall of Device Recall Respironics V60 Ventilator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics California Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56147
  • Event Risk Class
    Class 2
  • Event Number
    Z-0457-2011
  • Event Initiated Date
    2010-07-02
  • Event Date Posted
    2010-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92745
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, continuous, minimal ventilatory support,facility use - Product Code MNT
  • Reason
    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.
  • 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.

Device

Device Recall Respironics V60 Ventilator
  • Model / Serial
    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 Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    Respironics V60 Ventilator, manufactured by Respironics California Inc. in Carlsbad, CA.
  • Manufacturer
    Respironics California Inc

Manufacturer

Respironics California Inc
  • Manufacturer Address
    Respironics California Inc, 2271 Cosmos Ct, Carlsbad CA 92011
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA