Devices

Device Recall INSTRUMENT ARM DRAPE

  • 모델명 / 제조번호(시리얼번호)
    Part number: 420015-03;  Lot numbers: D120745A, D120765, D120795, D120845, D120895A, D120935, D120955.  EXPANDED - added lot DA121075.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of: Australia, Spain, India, Italy and Saudi Arabia.
  • 제품 설명
    INSTRUMENT ARM DRAPE IS2000, 20 PACK: || Product Usage: || The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
  • Manufacturer
    Intuitive Surgical, Inc.
  • 1 Event

제조사

Intuitive Surgical, Inc.
  • 제조사 주소
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • 제조사 모회사 (2017)
    Intuitive Surgical Inc
  • Source
    USFDA

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 1 건

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Device Recall INSTRUMENT ARM DRAPE, IS4000, 20 PACK
  • 모델명 / 제조번호(시리얼번호)
    Manufacturing lot numbers: 470015-05, 470015-06. System numbers: SK0194 SK0312 SK0182 SK0195 SK0313 SK0241 SK0321 SK0131 SK0117 SK0149 SK0068 SK0197 SK0329 SK0185 SK0183 SK0253 SK0142 SK0141 SK0078 SK0128 SK0224 SK0192 SK0381 SK0085 SK0086 SK0247 SK0109 SK0088 SK0199 SK0200 SK0201 SK0215 SK0223 SK0336 SK0164 SK0256 SK0202 SK0214 SK0089 SK0165 SK0374 SK0374 SK0124 SK0260 SK0323 SK0252 SK0319 SK0327 SK0373 SK0335 SK0129 SK0184 SK0229 SK0110 SK0111 SK0350 SK0351 SK0136 SK0132 SK0190 SK0290 SK0158 SK0207 SK0341 SK0246 SK0226 SK0187 SK0232 SK0303 SK0328 SK0330 SK0315 SK0334 SK0204 SK0248 SK0344 SK0322 SK0219 SK0353 SK0222 SK0154 SK0318 SK0217 SK0196 SK0221 SK0172 SK0218 SK0220 SK0379 SK0213 SK0108 SK0177 SK0179 SK0101 SK0170 SK0233 SK0309 SK0234 SK0235 SK0105 SK0104 SD0002 SK0240 SK0360 SK0203 SK0091 SK0106 SK0206 SK0326 SK0294 SK0291 SK0237 SK0293 SK0238 SK0292 SK0272 SK0273 SK0356 SK0148 SK0095 SK0347 SK0135 SD0001 SK0259 SK0167 SK0371 SK0152 SK0087 SK0159 SK0225 SK0069 SK0099 SK0257 SK0178 SK0061 SK0343 SK0064 SK0163 SK0065 SK0180 SK0346 SK0285 SK0348 SK0280 SK0383 SK0239 SK0209 SK0258 SK0352 SK0331 SK0308 SK0271 SK0264 SK0358 SK0216 SK0039 SK0263 SK0162 SK0270 SK0059 SK0120 SK0143 SK0144 SK0279 SK0338 SK0265 SK0267 SK0051 SK0266 SK0316 SK0339 SK0145 SK0139 SK0074 SK0255 SK0314 SK0147 SK0186 SK0082 SK0295 SK0174 SK0055 SK0119 SK0058 SK0134 SK0242 SK0333 SK0250 SK0342 SK0302 SK0084 SK0092 SK0166 SK0090 SK0269 SK0114 SK0113 SK0375 SK0268 SK0296 SK0299 SK0168 SK0324 SK0300 SK0245 SK0083 SK0231 SK0287 SK0098 SK0298 SK0198 SK0275 SK0067 SK0066 SK0096 SK0254 SK0103 SK0230 SK0208 SK0070 SK0093 SK0332 SK0205 SK0044 SK0301 SK0094 SK0278 SK0286 SK0075 SK0317 SK0137 SK0349 SK0284 SK0122 SK0138 SK0146 SK0249 SK0320 SK0057 SK0228 SK0210 SK0079 SK0176 SK0155 SK0150 SK0156 SK0097 SK0307 SK0157 SK0288 SK0304 SK0244 SK0054 SK0123 SK0188 SK0189 SK0072 SK0175 SK0193 SK0062 SK0100 SK0382 SK0376 SK0173 SK0297 SK0261 SK0181 SK0063 SK0130 SK0359 SK0274 SK0112 SK0140 SK0262 SK0036 SK0236 SK0050 SK0378 SK0169 SK0081 SK0076 SK0345 SK0077 SK0380 SK0310 SK0211 SK0277 SK0276 SK0071 SK0227 SK0153 SK0048 SK0191 SK0289 SK0046 SK0127 SK0340 SK0160 SK0047 SK0049 SK0161 SK0171 SK0311 SK0073 SK0151 SK0325 SK0243 SK0115 SK0116 SK0212.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Austria, Belgium, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Netherlands, Norway, Puerto Rico, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.
  • 제품 설명
    INSTRUMENT ARM DRAPE, IS4000, 20 PACK; used on the da Vinci Xi Surgical System. || The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.
  • Manufacturer
    Intuitive Surgical, Inc.