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Devices
Device Recall KCI
모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Physical Medicine Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189
Manufacturer
Kinetic Concepts, Inc
1 Event
Device Recall KCI 의 리콜
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제조사
Kinetic Concepts, Inc
제조사 주소
Kinetic Concepts, Inc, 4958 Stout Dr, San Antonio TX 78219-4334
Source
USFDA
유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 3 건
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Device Recall KCI TriaDyne Proventa
모델명 / 제조번호(시리얼번호)
The following serial numbers: TDBK00029, TDBK00294, TDBK00015, TDBK00291, TDBK00026, TDBK00027, TDBK00123, TDBK00124, TDBK00125, TDBK00127, TDBK00128, TDBK00130, TDBK00132, TDBK00136
의료기기 분류등급
Physical Medicine Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
KCI TriaDyne Proventa Critial Care Therapy System, manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78219. Model number 308900
Manufacturer
Kinetic Concepts, Inc
Device Recall KCI Therapulse II
모델명 / 제조번호(시리얼번호)
Serial numbers: TPLK00053, TPLK00052, TPLK00011, TPLK00012, TPLK00013, TPLK00014, TPLK00015, TPLK00016, TPLK00124, TPLK00128, TPLK00132
의료기기 분류등급
Physical Medicine Devices
의료기기 등급
2
이식된 장치?
No
유통
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
제품 설명
KCI Therapulse II Air Suspension Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX 78219. Model number 227080
Manufacturer
Kinetic Concepts, Inc
Device Recall KCI RotoProne Critical Care Therapy
모델명 / 제조번호(시리얼번호)
Serial numbers: RRFK0036-RRFK00047; RRFK00049-RRFK00115; RRFK00117-RRFK00128; RRFK00141-RRFK00211; RRFK00213-RRFK00233; RRFK00235; RRFK00237-RRRFK00254; RRFK00256-RRFK00261; RRFK00263-RRFK00267; RRFK00269-RRFK00270; RRFK00273-RRFK00280; RRFK00282-RRFK00284; RRFK00287-RRFK00290; and RRJK00002.
의료기기 분류등급
Physical Medicine Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - USA and Kuwait.
제품 설명
KCI RotoProne Critical Care Therapy System buckles for securing patient to the surface during proning therapy, Model 209500. || Indicated for treatment and prevention of pulmonary complications.
Manufacturer
KCI USA, Inc.
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