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Devices
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
모델명 / 제조번호(시리얼번호)
Product code 16-02-83 Serial number 16S11455-16S15190
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
제품 설명
Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
1 Event
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T 의 리콜
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제조사
Sorin Group USA, Inc.
제조사 주소
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
제조사 모회사 (2017)
LivaNova PLC
Source
USFDA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 5 건
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Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
모델명 / 제조번호(시리얼번호)
Product code 16-02-80 Serial number 16S10027-16S15641
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
제품 설명
Sorin Stockert Heater-Cooler 3T, 230 V || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
모델명 / 제조번호(시리얼번호)
Product code 16-02-81 Serial number 16S10743-16S11708
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
제품 설명
Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
모델명 / 제조번호(시리얼번호)
Product code 16-02-82 Serial number 16S10772-16S15523
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
제품 설명
Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
모델명 / 제조번호(시리얼번호)
Product code 16-02-85 Serial number 16S10958-16S15634
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
제품 설명
Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
모델명 / 제조번호(시리얼번호)
Product code 16-02-95 Serial number 16S12004-16S15385
의료기기 분류등급
Cardiovascular Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - US (nationwide) and Internationally to AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SK, AE, AR, AU, AZ, BD, BH, BR, BY, CA, CL, CN, CO, CR, DZ, EC, EG, ET, GE, GY, HK, ID, IL, IN, IQ, IR, JO, JP, KR, KW, KZ, LB, LK, LY, MA, MN, MU, MX, MY, NG, NP, NZ, OM, PA, PE, PH, PK, PR, PS, QA, RE, RU, SA, SG, SV, SY, TH, TN, TR, TT, TW, UA, VN, ZA.
제품 설명
Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz || Temperature control for extracorporeal perfusion of durations up to 6 hours.
Manufacturer
Sorin Group USA, Inc.
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