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Crédits
Devices
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Modèle / numéro de série
Product code 16-02-95 Serial number 16S12004-16S15385
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
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.
Description du dispositif
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.
1 Event
Rappel de Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
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Fabricant
Sorin Group USA, Inc.
Adresse du fabricant
Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004-3503
Société-mère du fabricant (2017)
LivaNova PLC
Source
USFDA
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Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Modèle / numéro de série
Product code 16-02-80 Serial number 16S10027-16S15641
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
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.
Description du dispositif
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
Modèle / numéro de série
Product code 16-02-81 Serial number 16S10743-16S11708
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
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.
Description du dispositif
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
Modèle / numéro de série
Product code 16-02-82 Serial number 16S10772-16S15523
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
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.
Description du dispositif
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
Modèle / numéro de série
Product code 16-02-83 Serial number 16S11455-16S15190
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
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.
Description du dispositif
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.
Device Recall STOCKERT HEATERCOOLER SYSTEM 3T
Modèle / numéro de série
Product code 16-02-85 Serial number 16S10958-16S15634
Classification du dispositif
Cardiovascular Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
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.
Description du dispositif
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.
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