Device Recall BCI Advisor

  • Model / Serial
    Serial Number AM07030098 AM07030097 AM07030100 AM07030099 AM07030018 AM07020155 AM07020154 AM07020152 AM07020153 AM07030010 AM07030005 AM07030013 AM07030014 AM07030015 AM07030012 AM07030006 AM07030008 AM07030011 AM07030016 AM07030017 AM07030004 AM07030009 AM07030007 AM07030000 AM07030001 AM07030101 AM07030103 AM07030019 AM07020159 AM07020164 AM07020163 AM07020161 AM07020165 AM07020166 AM07020157 AM07020162 AM07020158 AM07020160 AM07020049 AM07020047 AM07020039 AM07020048 AM07020050 AM07020064 AM07030002 AM07030003 AM07030148 AM07030114 AM07020179 AM07020168 AM07020167 AM07030112 AM07020173 AM07020172 AM07020126 AM07030109 AM07020169
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution Only: Czech Republic, Peru, Argentina, Pakistan, Greece, Romania, The Netherlands, Germany, Puerto Rico, United Kingdom, Brazil, Uruguay, Spain, Australia, and Israel
  • Product Description
    BCI Advisor Vital Signs Monitor (Model/Catalog Number: 9200)
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Smiths Medical PM, Inc., N7w22025 Johnson Dr, Waukesha WI 53186-1856
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Serial Numbers: 4059587 through 4059591  UPDATED 4-20-2015: additional devices affected have serial numbers: 4059949, 4059950, 4059951, 4059952, 4059953, 4059954, 4059955, 4059957, 4059958 and 4059960
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MN
  • Product Description
    Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A.
  • Manufacturer
  • Model / Serial
    serial numbers: AM08070014, AM08070015, AM08080004, AM08080005, AM08080006, AM08080007, AM08080008, AM08080009, AM08080010, AM08080011, AM08080012, AM08080013, AM08080014, AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08080032, AM08080033, AM08080034, AM08080035, AM08080036, AM08080037, AM08080038, AM08080039, AM08080040, AM08080041, AM08080042, AM08080043, AM08080044, AM08080045, AM08080046, AM08080047, AM08080048, AM08080049, AM08080050, AM08080051, AM08080052, AM08080075, AM08080076, AM08080077, AM08080078, AM08080079, AM08090058, AM08090059, AM08090060, AM08090061, AM08090069, AM08090070, AM08090071, AM08090072, AM08090073, AM08090074, AM08090075, AM08090076, AM08090077, AM08090078, AM08090079, AM08090080, AM08090081, AM08090082, AM08090083, AM08090084, AM08090085, AM08090086, AM08090092, AM08090093, AM08090094, AM08090095, AM08090096, AM08090097, AM08100000, AM08100001, AM08100002, AM08100003, AM08100004, AM08100005, AM08100006, AM08100007, AM08100008, AM08100042, AM08100043, AM08100045, AM08100051, AM08100052, AM08100053, AM08100054, AM08100056, AM08100075, AM08100076, AM08100077, AM08100078, AM08100080, AM08100082, AM08100083, AM08100085, AM08100086, AM08100087, AM08100088, AM08100089, AM08100091, AM08100092, AM08100093, AM08100094, AM08100095, AM08100096, AM08100097, AM08100098, AM08100099, AM08100100, AM08100101, AM08100146, AM08110000, AM08110001, AM08110003, AM08110004, AM08110005, AM08110008, AM08110009, AM08110010, AM08110011, AM08110012, AM08110013, AM08110014, AM08110015, AM08110016, AM08110018, AM08110019, AM08110026, AM08110027, AM08110028, AM08110029, AM08110030, AM08110031, AM08110034, AM08110035, AM08110036, AM08110037, AM08110054, AM08110055, AM08110056, and AM08110058.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA including states of FL, GA, NJ, NY, and TN and countries of Argentina, Brazil, Ecuador, Greece, Peru, Romania, Russia, Singapore, Slovenia, Trinidad and Tobago, United Kingdom, and Uruguay.
  • Product Description
    Smiths Medical BCI(R) Advisor(R) Vital Signs Monitor, model 9200, catalog numbers: 920654225, 920674225, 920674235, 925454220, 925454235, 925454320, 925454325, 925454330, 925454335, 925457325, 925474325, 925654225, 925654325, 925754325, 925754335, and 92M774325. || Intended to be used in the ICU, CCU, OR, ER, RR, Labor and Delivery rooms, special procedure labs and other areas of a hospital or clinic where low-end monitoring systems are needed.
  • Manufacturer