Events

Recall of REMstar Heated Humidifier

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics, 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
    36649
  • Event Risk Class
    Class 2
  • Event Number
    Z-0446-2007
  • Event Initiated Date
    2006-10-25
  • Event Date Posted
    2007-01-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49054
  • 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
    Humidifier - Product Code BTT
  • Reason
    Ac inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device.
  • Action
    The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.

Device

REMstar Heated Humidifier
  • Model / Serial
    Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861. Serial numbers range affected H045582 through H239662. Individual serial numbers are: H000524, H000546, H00593, H000596, H000599, H000967, H001052, H001054, H001320, H001394, H001454, H001537, H001555, H001589, H001614, H001631, H001964, H002120, H002421, H002491, H002582, H002794, H002817, H002822, H002978, H003083, H003590, H003665, H003739, H004117, H004747, H004804, H004971, H004978, H005289, H005405, H005411, H005416, H005534, H005550, H005577, H005681, H005876, H006214, H006448, H006665, H006700, H006711, H006819, H007080, H007104, H007683, H007828, H007907, H008213, H008295, H008348, H008452, H008549, H008588, H008733, H008956, H009282, H009670, H009797, H009838, H009858, H009894, H010883, H011283, H011636, H012040, H012080, H012120, H012288, H012621, H012737, H012819, H013327, H013346, H013727, H014040, H014432, H014449, H014541, H014565, H014752, H014753, H014898, H015446, H015760, H015761, H015848, H015859, H015873, H016071, H016112, H016276, H016552, H016629, H016665, H016753, H016895, H016913, H016926, H017170, H017195, H017270, H017294, H017382, H017483, H017905, H018031, H018037, H018435, H018717, H018735, H018963, H018965, H018995, H019041, H019069, H019088, H019348, H019362, H019371, H019385, H019586, H019685, H019786, H019807, H019837, H019839, H019867, H019923, H019985, H020053, H020253, H020502, H020518, H020538, H020562, H020572, H020583, H020597, H020606, H020647, H020713, H020727, H020739, H020754, H020889, H021619, H021781, H021838, H021943, H022085, H022283, H022286, H022297, H022366, H022369, H022412, H022512, H022514, H023004, H023159, H023331, H023583, H023602, H023720, H023745, H023791, H023797, H023821, H023912, H024779, H025127, H025226, H025304, H025317, H025321, H025398, H025434, H025560, H025969, H026008, H026132, H026156, H026158, H026199, H026202, H026206, H026207, H026364, H026405, H026425, H026726, H026759, H027046, H027122, H027239, H027478, H027507, H027694, H027765, H027904, H027986, H028025, H028080, H028282, H028408, H028549, H028594, H029078, H029429, H029529, H029538, H029564, H029808, H029875, H029923, H030136, H030151, H030244, H030407, H030491, H030672, H030937, H031059, H031064, H031089, H031119, H031220, H031245, H031255, H031270, H031300, H031370, H031386, H031434, H031484, H031486, H031602, H031766, H031857, H031893, H032112, H032130, H032289, H032298, H032418, H032672, H032762, H032788, H032794, H032806, H032923, H033048, H033134, H033171, H033286, H033305, H033400, H034422, H034493, H034624, H034687, H034704, H035098, H035138, H035270, H035295, H035801, H035954, H036042, H036268, H036440, H036655, H036878, H037043, H037203, H037235, H037343, H037433, H037585, H037592, H037897, H038061, H038147, H038170, H038254, H038500, H038507, H038657, H038720, H038789, H038915, H038921, H039024, H039084, H039157, H039231, H039420, H039431, H039542, H039922, H040025, H040133, H040300, H040349, H040403, H040462, H040480, H040493, H040590, H040912, H041200, H041254, H041298, H041322, H041346, H041595, H041879, H041884, H041886, H041892, H041896, H042261, H042419, H042420, H042527, H042912, H042992, H042997, H043012, H043461, H043494, H043692, H043763, H043877, H043973, H043991, H044274, H044317, H044338, H044128, H044185, H044414, H044468, H044480, H044544, H044565, H044759, H044849, H044878, H044909, H044954, H045276, H045381, H045406, H045466, H045486, H045494, H045498, and HO45514.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution ---- including USA and countries of Denmark, Austria, France, Canada, Netherlands, Japan, Hong Kong, Austrailia, Great Britain, Spain, Belgium, Germany, Poland, Ireland, Portugal, Saudia Arabia, Korea, Mexico, Finland, Taiwan, Philippines, Iceland, Brazil, Kuwait, New Zealand, Chile, India, Egypt, Norway, Turkey, Jordan, Thailand, Hungary, Russia, Peru, South Africia, Israel, Czech, Pakistan, Lebanon, Venezuela, Sweden, United Arab Emirates, Qatar, Slovakia, Bulgaria, Bermuda, and Colombia.
  • Product Description
    REMstar Heated Humidifier ( Respiratory Gas Humidifer) Model numbers 1005792, U1005792, R1005792, SC1005792, AC1005792, 1007861, R1007861, and JP1007861.
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Manufacturer Address
    Respironics, Inc., 1001 Murry Ridge Ln, Murrysville PA 15668-8550
  • Manufacturer Parent Company (2017)
    Philips
  • Source
    USFDA