Device Recall Fabius GS

  • 모델명 / 제조번호(시리얼번호)
    catalog #8604699
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA and countries of Brazil, Canada, Columbia, Costa Rica, Cuba, Ecuador, Japan, Lebanon, Nicaragua, Mexico, Panama, Philippines, Saudi Arabia, Taiwan, and Venezuela
  • 제품 설명
    Fabius GS Anesthesia Machine, OR/Anesthesia, Draeger Medical, Inc., 3135 Quarry Road, Telford, PA 18969 || inhalation anesthesia machine for use in operating, induction and recovery rooms
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Draeger Medical Systems, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Serial no: ASKF-0224 ASKF-0232 ASKH-0004 ASKH-0007 ASKH-0038 ASKH-0088 ASKH-0132 ASKH-0133 ASKJ-0007 ASKJ-0178 ASKJ-0179 ASKJ-0184 ASKJ-0205 ASKJ-0220 ASKJ-0224 ASKK-0002 ASKK-0006 ASKK-0010 ASKK-0011 ASKK-0014 ASKK-0019 ASKK-0022 ASKK-0023 ASKK-0032 ASKK-0036 ASKK-0038 ASKK-0044
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution to accounts in 21 states: AZ, CA, CO, ID, IL, KS, MA, MI, MS, NC, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI; and PR.
  • 제품 설명
    Fabius GS Premium, anesthesia machine, catalog no. 8607000 || Product Usage: || The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ASKM-0102 ASKM-0220 ASKM-0103 ASKM-0221 ASKM-0124 ASKM-0222 ASKM-0125 ASKM-0223 ASKM-0129 ASKM-0224 ASKM-0132 ASKM-0229 ASKM-0133 ASKN-0061 ASKM-0134 ASKN-0090 ASKM-0135 ASLA-0035 ASKM-0136 ASLA-0046 ASKM-0137 ASLA-0047 ASKM-0138 ASLA-0048 ASKM-0139 ASLA-0049 ASKM-0189 ASLA-0050 ASKM-0190 ASLA-0053 ASKM-0191 ASLA-0070 ASKM-0192 ASLA-0071 ASKM-0193 ASLA-0072 ASKM-0194 ASLA-0073 ASKM-0195 ASLA-0074 ASKM-0198 ASLA-0075 ASKM-0199 ASLA-0129 ASKM-0200 ASLA-0131 ASKM-0201 ASLA-0133 ASKM-0202 ASLA-0140 ASKM-0204 ASLA-0141 ASKM-0205 ASLA-0159 ASKM-0207 ASLA-0199 ASKM-0208 ASLA-0200 ASKM-0215 ASLA-0201 ASKM-0219 ASLA-0218
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
  • 제품 설명
    Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 || Product Usage: || Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ASKM-0110 ASKM-0111 ASKM-0196 ASKM-0209 ASKM-0232 ASKM-0244 ASKM-0246 ASKN-0032 ASKN-0033 ASKN-0034 ASKN-0037 ASKN-0041 ASKN-0043 ASKN-0068 ASKN-0093 ASLA-0009 ASLA-0021 ASLA-0023 ASLA-0031 ASLA-0032 ASLA-0123 ASLA-0130 ASLA-0135 ASLA-0136 ASLA-0147 ASLA-0155 ASLA-0158 ASLA-0163 ASLA-0166 ASLA-0170 ASLA-0195
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
  • 제품 설명
    Fabius GS Tiro Anesthesia Machine; Cat. no. 8606000 || Product Usage: || Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    ASLA-0017 ASLA-0018 ASLA-0019 ASLA-0020
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution - Healthcare facilities in AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, MA, MD, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, WA, WI, and WV.
  • 제품 설명
    Fabius GS MRI Anesthesia Machine; Cat. no. 8607300 || Product Usage: || Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Controlled Ventilation Pressure Support (Optional) SIMV/PS (Optional) Manual Ventilation Spontaneous Breathing Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2). As per IEC 60601-2-13 (Anesthetic Workstations and their Modules-Particular Requirements), additional monitoring of the concentrations of CO2 and anesthetic agent is required when the machine is in use. IEC 60601-2-13:2003 requires that a manual ventilation bag must be available for emergency use. Fresh gas enrichment is provided by the Dr¿ger Vapor anesthetic vaporizer. Fabius MRI can also be used in MRI scanner rooms with magnets 1.5 tesla and 3 tesla at a fringe field strength of 40 mtesla or less
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: ARWM0008, ARWM0009, ARWM0010, ARWM0011, ARWM0012, ARWM0013, ARWM0014, ARWM0015, ARWM0029, ARWM0030, ARWM0031, ARWM0032, ARWM0033, ARWM0034, ARWM0035, ARWM0036, ARWM0037, ARWM0050, ARWM0051, ARWM0052, ARWM0053, ARWM0057, ARWM0058, ARWM0059, ARWM0061, ARWM0062, ARWM0063, ARWM0064, ARWM0065, ARWM0066, ARWM0067, ARWM0068, ARWM0069, ARWM0070, ARWM0071, ARWM0072, ARWM0073, ARWM0074, ARWM0075, ARWM0076, ARWM0077, ARWM0078, ARWM0079, ARWM0080, ARWM0081, ARWM0082, ARWM0083, ARWM0084, ARWM0085, ARWM0092, ARWM0093, ARWM0097, ARWM0098, ARWM0099, ARWM0100, ARWM0101, ARWM0102, ARWM0103, ARWM0104, ARWM0105, ARWM0108, ARWM0112, ARWM0113, ARWM0114, ARWM0115, ARWM0116, ARWM0117, ARWM0118, ARWM0119, ARWM0120, ARWM0121, ARWM0122, ARWM0123, ARWM0124, ARWM0125, ARWM0126, ARWM0127, ARWM0128, ARWM0129, ARWM0130, ARWM0131, ARWM0132, ARWM0133, ARWM0134, ARWM0135, ARWM0136, ARWM0137, ARWM0138, ARWM0139, ARWM0140, ARWM0157, ARWM0159, ARWM0160, ARWM0161, ARWM0162, ARWM0163, ARWM0164, ARWM0165, ARWM0167, ARWM0168, ARWM0169, ARWM0170, ARWM0171, ARWM0172, ARWM0176, ARWM0177, ARWM0178, ARWM0179, ARWM0180, ARWM0181, ARWM0184, ARWM0215, ARWM0216, ARWM0217, ARWM0219, ARWM0224, ARWM0232, ARWM0284, ARWM0285, ARWM0286, ARWM0287, ARWM0288, ARWM0289, ARWM0308, ARWM0309, ARWM0310, ARWM0311, ARWM0313, ARWM0314, ARWM0315, ARWM0323, ARWM0326, ARWM0327, ARWM0328, ARWM0329, ARWM0330, ARWM0331, ARWM0333, ARWM0335, ARWM0337, ARWN0001, ARWN0002, ARWN0003, ARWN0005, ARWN0014, ARWN0015, ARWN0016, ARWN0017, ARWN0018, ARWN0019, ARWN0022, ARWN0023, ARWN0024, ARWN0025, ARWN0026, ARWN0027, ARWN0028, ARWN0029, ARWN0030, ARWN0031, ARWN0033, ARWN0034, ARWN0035, ARWN0036, ARWN0037, ARWN0038, ARWN0039, ARWN0040, ARWN0041, ARWN0042, ARWN0043, ARWN0044, ARWN0045, ARWN0046, ARWN0058, ARWN0060, ARWN0061, ARWN0062, ARWN0063, ARWN0064, ARWN0065, ARWN0066, ARWN0067, ARWN0076, ARWN0078, ARWN0080, ARWN0081, ARWN0082, ARWN0083, ARWN0084, ARWN0085, ARWN0087, ARWN0088, ARWN0176, ARWN0184, and ARWN0214.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Fabius GS Anesthesia Machine; Gas machine for anesthesia or analgesia; Catalog Number: 8604700; Drager Medical Inc, Telford, PA 18969.
  • Manufacturer