{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "219095", "product_res_number": "Z-2310-2026", "event_date_initiated": "2026-04-24", "event_date_posted": "2026-06-04", "recall_status": "Open, Classified", "res_event_number": "98569", "product_code": "NAY", "k_numbers": [ "K232610" ], "product_description": "Brand Name: Da Vinci 5\nProduct Name: ASSY,DV5 TOWER,IS5000\nModel/Catalog Number: 380746\nSoftware Version: N/A\nProduct Description: Preface: \nThis report under 21 CFR 806.10 is being submitted for the dV5 system tower, as the NIR Handheld Camera or SOCK is developed and integrated as part of the dV5 system. The affected component of the dV5 system tower is the NIR handheld camera, and is supplied by Schoelly as the manufacturer. Therefore, the product description in this report references the NIR handheld camera system.\n\nProduct Description: \nThe NIR handheld camera system is compatible for use with the da Vinci 5 system to aid in\nsurgery. The components of the NIR handheld camera system include a camera control unit\nand a light source, NIR handheld camera, and additional components that together, connect\nto the Tower of the da Vinci 5 system. When setting up the da Vinci 5 system, the image from\nthe NIR handheld camera system is displayed on the Tower monitor.\nComponent: Yes, the SOCK is the component and integrated into the dV5 system", "code_info": "Lot Code: Part Number: 380746\nUDI: 00886874119662\nFDA Medical Device Listing Number: D531324\n(U.S.)\nPart Number: 470653-01\nSerial 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Number: 470653-03\nSerial Numbers:\n1186136\n1186139\n1157705\n1157706\n1157721\n1161015\n1161017\n1161028\n1161029\n1161030\n1161056\n1161064\n1161066\n1161067\n1161068\n1161069\n1161070\n1161071\n1161073\n1161074\n1161075\n1161076\n1161077\n1161078\n1161080\n1161081\n1161082\n1161149\n1161150\n1164405\n1164407\n1164428\n1164449\n1164450\n1164455\n1164456\n1164464\n1164465\n1164466\n1164519\n1164520\n1164522\n1164523\n1164524\n1164525\n1164526\n1164527\n1164528\n1164530\n1164531\n1164532\n1164533\n1164537\n1164541\n1164545\n1164549\n1164550\n1166267\n1166268\n1166269\n1166272\n1166273\n1166275\n1166276\n1166280\n1166281\n1166285\n1166312\n1166313\n1166314\n1166316\n1166323\n1166325\n1166328\n1166329\n1166330\n1166331\n1166333\n1166334\n1166336\n1168930\n1168932\n1168933\n1168934\n1168938\n1168939\n1168941\n1168942\n1168943\n1168944\n1168945\n1168946\n1168947\n1168950\n1168953\n1168954\n1168955\n1168956\n1168962\n1168968\n1171019\n1171036\n1171038\n1171039\n1171040\n1171041\n1171043\n1171045\n1171059\n1171060\n1171062\n1171063\n1171069\n1171072\n1171073\n1176677\n1176698\n1176741\n1176742\n1176743\n1176744\n1176745\n1176746\n1176748\n1176749\n1176750\n1176751\n1176752\n1178538\n1178543\n1178555\n1178567\n1179195\n1179201\n1179203\n1179224\n1179225\n1179226\n1179228\n1179229\n1179231\n1179232\n1179254\n1179255\n1179276\n1179277\n1179298\n1179299\n1179300\n1179301\n1179312\n1179313\n1179333\n1179338\n1179340\n1179343\n1181818\n1181819\n1181820\n1181822\n1181823\n1181824\n1181825\n1181827\n1181828\n1181830\n1181832\n1181833\n1181855\n1181857\n1181861\n1184449\n1186134\n1186135\n1186145\n1186168\n1186374\n1186385\n1187866\n1188191\n1188194\n1188195\n1188206\n1188207\n1188208\n1188209\n1188210\n1188211\n1188212\n1188213\n1188219\n1188220\n1188222\n1190015\n1190016\n1190017\n1190018\n1190019\n1190021\n1190022\n1190023\n1190025\n1190029\n\n(O.U.S.)\nPart Number: 470653-01\nSerial Numbers:\n1014033\n1014035\n1014142\n1014157\n1014161\n1014162\n1026777\n1026778\n1026785\n1028055\n1028081\n1028084\n1043799\n1043800\n1043801\n1043821\n1043895\n1043898\n1045998\n1046052\n1047715\n1047717\n1137738\n1137745\n1140562\n1140569\n1140584\n1140589\n1140591\n1140592\n\nPart Number: 470653-03\nSerial Numbers:\n1179196\n1161059\n1168931\n1171068\n1159334\n1157750\n1157748\n1166282\n1157753\n1171021\n1168936\n1161053\n1157758\n1164454\n1164467\n1159327\n1159259\n1159329\n1157702\n1157757\n1159331\n1164548\n1157759\n1161060\n1186384\n1171066\n1161079\n1157756\n1159330\n1164457\n1159328\n1168966\n1159335\n1164406\n1157751\n1168969\n1166266\n1161054\n1168951\n1159326\n1159332\n1159324\n1157120\n1166283", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Shahbaz Khan\n1-408-5232443", "reason_for_recall": "Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope.", "root_cause_description": "Device Design", "action": "On 04/24/2026, the firm emailed an \"Urgent Medical Device Correction\" Letter to customers informing them that Intuitive has identified a condition in which the NIR modes may remain active unintentionally when attempting to turn off visible white light illumination during normal clinical workflow transitions, when switching from the handheld camera to the robotic endoscope and may result in thermal injury if the distal end of the light guide (detached) or assembled laparoscope contacts the patient, user, or sterile drapes while NIR mode is active.\n\nCustomer Actions required for Continued Use of dV5 Systems Equipped with the NIR Handheld Camera:\n\"Prior to each use, ensure that the NIR Handheld Camera Light Source indicators remain visible to operating room staff so that the laser status can be confirmed. Position the dV5 Tower Monitor and other equipment so the Light Source indicators are not obstructed from view.\n\"The Tower Monitor should be positioned to avoid obstructing the Light Source indicators to maintain clear visibility of the CCU during use. Monitor positioning may vary based on Operating Room configuration. Refer to the Near Infrared Handheld Camera System User Manual (PN 557076-02) for additional setup guidance.\n\"The indicators include:\n- LASER ON status indicator\n-Laser symbol on the LCD display\n-Green-colored button backlights\n\"Prior to placing the device on the patient or sterile drapes, confirm that the Light Source is in Standby Mode, as indicated by white-colored button backlights and Standby on the LCD display.\n\"Press and hold the green up arrow button on the Camera Head for approximately 2.5 seconds to deactivate the light source.\n\"Be aware of the following Cautions stated in the Handheld Camera Light Guide IFU (Schoelly s reference: TPA801-460-01; Intuitive s reference: PN 557072-01):\n\nFor questions/support, Clinical Sales Rep or Intuitive Customer Service at the numbers listed below:\n\"North and South America: (800) 876-1310, Option 3 (4 am", "product_quantity": "1357 systems", "distribution_pattern": "U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NH, NJ, NM, NV, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.\n\nO.U.S.: Australia, Belgium, France, Germany, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Saudi Arabia, South Korea, Spain, Switzerland, and United Kingdom", "openfda": { "k_number": [ "K200049", "K170879", "K171120", "K141075", "K130726", "K230033", "K080291", "K061260", "K223095", "K150837", "K183107", "K231798", "K232773", "K212747", "K251227", "K241638", "K143217", "K254192", "K131962", "K162411", "K183224", "K081207", "K162973", "K240852", "K101743", "K243641", "K253556", "K170875", "K170644", "K122532", "K022574", "K211595", "K040237", "K183098", "K012833", "K192717", "K200473", "K242318", "K241814", "K060391", "K252069", "K213710", "K181517", "K123840", "K183086", "K222827", "K081137", "K171426", "K180351", "K143132", "K040948", "K110451", "K173337", "K112584", "K251324", "K182421", "K152448", "K161178", "K042855", "K191482", "K002489", "K220023", "K141077", "K171294", "K050802", "K172643", "K170645", "K261824", "K161271", "K240502", "K223080", "K251213", "K140189", "K241284", "K082497", "K030578", "K110639", "K243714", "K150284", "K050369", "K171388", "K063220", "K152578", "K171947", "K191529", "K153276", "K182140", "K202834", "K171632", "K220889", "K232610", "K021036", "K140553", "K203632", "K173721", "K180033", "K202968", "K011281", "K152421", "K211325", "K021152", "K990144", "K191736", "K251202", "K093217", "K171699", "K252675", "K130266", "K242427", "K222839", "K043153", "K121921", "K202571", "K131861", "K180163", "K233866", "K011002", "K101581", "K170713", "K170641", "K211316", "K251426", "K214095", "K170508", "K173585", "K231224", "K142683", "K182371", "K212054", "K212101", "K253986", "K043288", "K191280", "K250442", "K251817", "K250674", "K151794", "K152892", "K123329", "K090993", "K113706", "K120215", "K211997", "K243582", "K211784", "K210918", "K251739", "K240723", "K050005", "K072627", "K190999", "K192877", "K173842", "K260695", "K070947", "K202166", "K170865", "K173906", "K250786", "K192803", "K112208", "K252350", "K173415", "K123463", "K112263" ], "registration_number": [ "3016607092", "3005369776", "3042953929", "1061124", "3020331900", "3010157088", "2936485", "3011063460", "3031594238", "3012811961", "3010860245", "9681503", "3018907196", "3011390076", "3012627460", "3014579024", "3010564249", "1721686", "9614969", "3010193531", "3022626486", "8010456", "1058584", "3016079756", "3038187466", "3013283620", "3014663814", "3016555232", "3009719225", "2032098", "3017119401", "3012880598", "3015224777", "9611665", "3015895145", "3036035332", "3042940623", "1650907", "3014644276", "3039523130", "3015336263", "3010684280", "3014635169", "3008309062", "3009217531", "3048246462", "8010877", "3026606306", "2032112", "3015153469", "2022435", "3038284218", "3007029079", "3003898360", "3013665681", "3038188839", "3015612252", "3013077751", "2955842", "3001675293", 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"medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }