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Crédits
Manufacturers
Kinetic Concepts, Inc
Adresse du fabricant
Kinetic Concepts, Inc, 4958 Stout Dr, San Antonio TX 78219-4334
Source
USFDA
10 Events
Rappel de Device Recall KCI TriaDyne Proventa
Rappel de Device Recall KCI Therapulse II
Rappel de Device Recall Burke Bariatric Bed
Rappel de Device Recall KCI
Rappel de Device Recall KinAir MedSurg
Rappel de Device Recall RotoProne Therapy System
Rappel de Device Recall V.A.C. Abdominal Dressing System
Rappel de BariMaxx II bariatric bed
Rappel de V.A.C.
Rappel de V.A.C. ATS Wound Healing System
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10 dispositifs dans la base de données
Device Recall KCI TriaDyne Proventa
Modèle / numéro de série
The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136
Classification du dispositif
Physical Medicine Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
Description du dispositif
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
Device Recall KCI Therapulse II
Modèle / numéro de série
Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132
Classification du dispositif
Physical Medicine Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
Description du dispositif
KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Device Recall Burke Bariatric Bed
Modèle / numéro de série
Serial numbers: B7A94031025, B7A94031024, B7A94031023, 000000093101003, 000000093101005, B7A94031010, B7A94031011, B7A94031012, B7A94031013, B7A94031014, B7A94031015, B7A94031030, B7A94031031, B7A94031032, 0498107/335AGJ
Classification du dispositif
General Hospital and Personal Use Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
Description du dispositif
Burke Bariatric Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX, model number 7064
Device Recall KCI
Modèle / numéro de série
Serial numbers: IVAK00004, IVAK00023, IVAK00028, IVAK00034, IVAK00033, IVAK00032, IVAK00055, IVAK00060, IVAK00062, IVAK00063, IVAK00030, IVAK50000, IVAK00030, IVAK00035, IVAK00027, IVAK00054, IVAK00037, IVAK00041, IVAK00049, IVAK00044, IVAK00045, IVAK00046, IVAK00047, IVAK00048, IVAK00038, IVAK00039, IVAK00042, IVAK00043, IVAK00051, 000038251, 000038253, 000038295, 000038299
Classification du dispositif
Physical Medicine Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
Product was distributed domestically in the following states: IN, CA, NH, OR, PA, TX, WI, CO, IA, KS, MO, ID, MA, NC, IL, OH, MN, AZ, NE, HI, PR, NC
Description du dispositif
KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
Device Recall KinAir MedSurg
Modèle / numéro de série
Serial Numbers KASK00001 through KASK01212
Classification du dispositif
Physical Medicine Devices
Classe de dispositif
2
Dispositif implanté ?
No
Distribution
The beds were distributed nationwide and to Brazil.
Description du dispositif
KinAir MedSurg, flotation therapy, powered hospital bed, manufactured by Kinetic Concepts, Inc., San Antonio, Texas
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Kinetic Concepts, Inc
Adresse du fabricant
Kinetic Concepts, Inc, 4958 Stout Drive, San Antonio TX 78219
Source
USFDA
Language
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