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Devices
Device Recall daVinci S Surgical System IS2000
모델명 / 제조번호(시리얼번호)
Model number IS2000, part number 351040-04. System numbers SG002, SG004, SG010 , SG032, SG060, SG061, SG064, SG065, SG066, SG067, SG068, SG069, SG070, SG071, SG072, SG073, SG074, SG075, SG076, SG077, SG078, SG079, SG080, SG081, SG082, SG083, SG084, SG086, SG090, SG116, SG117, SG118, SG120, SG121, SG126, SG174, SG175, SG184
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide, including USA, France, China, Japan, Mexico, Spain, Italy, Belgium and Singapore.
제품 설명
daVinci S Surgical system, patient side cart Auxiliary power board (APB) (printed circuit board assembly), endoscopic instrument control system.
Manufacturer
Intuitive Surgical, Inc.
1 Event
Device Recall daVinci S Surgical System IS2000 의 리콜
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제조사
Intuitive Surgical, Inc.
제조사 주소
Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
Source
USFDA
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Device Recall daVinci S Surgical System IS2000
모델명 / 제조번호(시리얼번호)
Model Number: IS 2000, Software Revision Numbers: A5.0 P5 and A5.1 P1. System Numbers: all starting with "SG"-- 043, 156, 088, 128, 065, 104, 106, 132, 019, 051, 058, 083, 092, 096, 165, 170, 098, 105, 157, 050, 112, 125, 138, 149, 034, 061, 121, 030, 044, 052, 054, 068, 069, 123, 147, 151, 013, 113, 152, 014, 049, 077, 134, 136, 066, 085, 091, 129, 087, 139, 140, 042, 047, 031, 089, 017, 021, 022, 115, 116, 137, 155, 168, 169, 041, 095, 119, 163, 164, 114, 057, 060, 101, 117, 122, 029, 020, 028, 056, 093, 094, 141, 103, 072, 084, 011, 024, 036, 053, 059, 144, 145, 146, 026, 074, 154, 018, 027, 055, 070, 109, 110, 111, 118, 120, 135, 099, 232, 033, 082, 148, 012, 015, 039, 067, 102, 124, 161, 166, 037, 097, 040, 064, 090, 127, 133, 025, 062, 143, 160, 038, 153, 035, 071, 073, 107, 158, 167, 086, 131, 063, 080, 078, 159, 076, 045, 081, 108, 150, 046, 075, 130, 004, 005, 006, 007, 010, 048, and 126
의료기기 분류등급
General and Plastic Surgery Devices
의료기기 등급
2
이식된 장치?
No
유통
Worldwide Distribution - USA, Belgium, China, France, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, UK and Mexico.
제품 설명
Intuitive Surgical, daVinci S Surgical System, Model Number: IS2000, A5.1 P1 and A5.0 P5 software level, Surgical Endoscopic Instrument Control System, Intuitive Surgical, Sunnyvale, CA 94086.
Manufacturer
Intuitive Surgical, Inc.
Language
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