Class 2 Device Recall Da Vinci SP1098 Patient Side Cart (PSC) EBrake Retainer Pin

• Date Initiated by Firm: April 22, 2026
• Date Posted: June 22, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2521-2026
• Recall Event ID: 98701
• 510(K)Number: K173906 K182371
• Product Classification: System, surgical, computer controlled instrument - Product Code NAY
• Product: Da Vinci ASSY, PSS, SP1098, Part Number: 380601
• Code Information: UDI: 00886874114605. Serial Numbers: 605408, 606848, 612328, 628399, 609353, 614073, 617794, 616769, 10008062, 635659, 631694, 638771, 641430, 694998, 645433, 643209, 954097, 656203, 764644, 656319, 946098, 667190, 666480, 655562, 664662, 680530, 679266, 683974, 674171, 676962, 682694, 686777, 701248, 696877, 688725, 688225, 697922, 700316, 698277, 702699, 709536, 701751, 717804, 705366, 704731, 724178, 703152, 722803, 693262, 736468, 736338, 740359, 742366, 732233, 696089, 724835, 716520, 709987, 728391, 751529, 731765, 672743, 766366, 711517, 735003, 735252, 746457, 746623, 718940, 721722, 691190, 744094, 750174, 738718, 10211920, 759253, 761448, 752536, 812651, 754935, 790597, 811147, 793019, 761000, 812650, 919988, 919987, 913011, 913012, 926423, 759791, 926422, 938794, 771653, 938795, 766365, 963841, 797872, 769736, 794437, 970568, 970562, 977045, 10003059, 957781, 973824, 804588, 10009706, 936269, 10003509, 930240, 936268, 800142, 10003510, 982782, 967667, 10009707, 973355, 944585, 10065786, 935214, 10020729, 10012963, 10020705, 10031145, 10031144, 973825, 10012962, 10036960, 963856, 10711066, 10035476, 795038, 10043635, 944583, 10072852, 10072853, 966079, 10069899, 10076490, 10087446, 10054478, 10080929, 954096, 10130089, 10165287, 942811, 10180162, 10172589, 10103483, 10103484, 10056518, 10092007, 10246370, 10209961, 10183740, 10232634, 504007, 10231116, 10211880, 10194911, 10245457, 10112470, 10189443, 977044, 10238314, 10644376, 10036961, 10274101, 10112471, 10238315, 10172574, 10281524, 10278366, 10252751, 10289629, 10293276, 10261900, 10274102, 10285085, 10281525, 10243796, 10267796, 10278365, 10285084, 10308532, 10318311, 10293274, 10323177, 10322512, 10289630, 10326939, 10293275, 10333333, 10326938, 10492299, 10302474, 10302473, 10368392, 10332310, 10346946, 10354749, 10346943, 10333332, 10346942, 10267795, 10323178, 10295600, 10223509, 10252780, 10396330, 10263730, 10354748, 10337879, 10265272, 10354750, 10384455, 10359960, 10368393, 10366206, 10375031, 10363897, 10396329, 10363898, 10375032, 10375033, 10409934, 10401560, 10409933, 10408268, 10294693, 10408269, 10396331, 10480883, 10499186, 10499185, 10384456, 10502598, 10495654, 10502599, 10505838, 10512168, 10512167, 10512166, 10508290, 10368391, 10556776, 10417803, 10526733, 10417164, 10508289, 10384454, 10492298, 10480878, 10526735, 10526736, 10537191, 10495655, 10526734, 10526732, 530114, 10537202, 10568118, 10308533, 10547839, 10564979, 10550219, 10564978, 10550220, 10550221, 10561240, 10594744, 10575228, 10571615, 10575229, 10583123, 10571614, 10556769, 10583124, 10594746, 10556777, 10564977, 10594743, 10579531, 10613173, 10568117, 10571616, 10615325, 10583126, 10619701, 10594742, 10541679, 10579530, 10561239, 10594745, 10615326, 10590323, 10590322, 10583125, 10615941, 10608089, 10644375, 10604955, 10561241, 10624252, 10647203, 10670710, 10672825, 10624990, 10295599, 10633489, 10622883, 10647201, 10624251, 10686903, 10612973, 10619702, 10672839, 10696000, 10615940, 10659191, 10651445, 10651443, 10682596, 10702363, 10644374, 10653815, 10651444, 10627633, 10686902, 10672840, 10627632, 10695999, 10665125, 10604956, 10480877, 10682597, 10694981, 10633487, 10716881, 10659189, 10728578, 10627631, 10702364, 10734551, 10659190, 10633488, 10734552, 10706206, 650202, 10744259, 10706207, 10766233, 10766236, 10793380, 10759158, 10759159, 10759161, 10763608, 10763609, 10808841, 10766234, 10763611, 10741377, 10759160, 10763610, 10826493, 10776325, 10766235, 10741378, 10744258, 10734553, 10808839, 10808840, 10771126, 10803470, 10793379, 10817400, 10798922, 10803484, 10766232, 10887260, 10830719, 10771125, 10776323, 10815457, 10744257, 10823000, 10776324, 10782092, 10873054, 10879012, 10897582, 10856718, 10889592, 10864698, 10922820, 10912617, 10647204, 10869722, 10889594, 10871773, 10845441, 10859690, 10826495, 10579532, 10782090, 10826494, 10792831, 10883203, 10871774, 10856716, 10856732, 10859689, 10947466, 10798915, 10968849, 10952495, 10957321, 10875232, 10903586, 10927370, 10947464, 10951328, 10981839, 10787962, 10908841, 10908842, 10817401, 10938311, 10933815, 10938312, 10955031, 10927371, 10933816, 10998396, 10927372, 10240354, 10998395, 11004904, 10979952, 10875231, 10912618, 10897581, 10938310, 10991256, 10991257, 10991259, 10895278, 10883202, 10889593, 10912619, 11016764, 11013103
• FEI Number: 3001675293
• Recalling Firm/ Manufacturer: Intuitive Surgical, Inc.; 1266 Kifer Rd; Sunnyvale CA 94086-5304
• For Additional Information Contact: Shahs Khan; 408-523-2443
• Manufacturer Reason for Recall: Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.
• FDA Determined Cause: Process control
• Action: On 4/22/2026, correction notices were mailed and emailed to customers who were asked to do the following: 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep a copy of the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. A firm Representative will schedule a site visit to perform an inspection of the system. If you need further information or support concerning this Medical Device Correction, please contact your da Vinci SP Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)
• Quantity in Commerce: 454
• Distribution: Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = NAY