{ "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": "2026-04-01", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Sunnyvale", "state": "CA", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "80947", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 101", "address_2": "", "postal_code": "94086-5304", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Ecuador, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Ireland, Israel, India, Italy, Japan, Korea, Kuwait, Luxembourg, Mexico, Netherlands, Norway, New Zealand, Romania, Russia, Saudi Arabia, Sweden, Singapore, Turkey, Taiwan, and Venezuela.", "recall_number": "Z-3254-2018", "product_description": "da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three components must be powered on for the system to be functional.", "product_quantity": "1,014 currently installed on systems", "reason_for_recall": "Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.", "recall_initiation_date": "20180716", "center_classification_date": "20180926", "termination_date": "20231005", "report_date": "20181003", "code_info": "Model Name: Model Number: UDI Number: da Vinci Si Surgical System IS3000 00886874110744 System/Console Name/Number: SH2433 SH2433 SH2406 SH2407 RSH0112 RSH0201 SH0948 SH2441 SH2409 SH2430 SH2412 SH2419 SH2409 SH2430 SH2441 SH2449 SH2446 SH2448 SH2402 SH2418 SH2421 SH2418 SH2404 SH2442 SH2421 SH2423 SH2425 SH2423 SH2426 SH2426 SH2442 SH2420 SH2415 SH2444 SH2422 SH2444 SH2435 SH2443 SH2431 SH2437 SH2447 SH2443 SH2445 SH2434 SH2450 RSH0159 RSH0137 RSH0140 RSH0165 RSH0204 RSH0167 RSH0166 RSH0180 RSH0181 RSH0205 RSH0229 RSH0155 RSH0163 RSH0160 RSH0170 SH2413 SH2413 SH2413 SH2408 RSH0210 SH2440 SH2410 SH2424 SH1681 RSH0126 SH0185 RSH0082 RSH0009 RSH0164 RSH0161 RSH0162 RSH0176 SC0042 SH1641 SH2038 SH0215 RSH0043 SH1133 RSH0209 SH0473 SH1786 RSH0120 SH2432 SH0272 SH0232 SC0045 SH0261 SH0925 SH0157 SH2436 SH2436 SH2438 da Vinci X Surgical System IS4200 00886874110683 System/Console Name/Number SL0028 SL0044 SL0015 SL0068 SL0132 SL0138 SL0052 SL0010 SL0008 SL0008 SL0074 SL0073 SL0101 SL0063 SL0094 SL0066 SL0081 SL0072 SL0069 SL0102 SL0100 SL0126 SL0126 SL0062 SL0061 SL0062 SL0136 SL0017 SL0041 SL0040 SL0039 SL0130 SL0091 SL0060 SL0022 SL0013 SL0012 SL0022 SL0059 SL0157 SL0065 SL0067 SL0133 SL0133 SL0113 SL0080 SL0076 SL0080 SL0047 SL0087 SL0079 SL0029 SL0050 SL0131 SL0042 SL0016 SL0057 SL0093 SL0129 SL0034 SL0037 SL0032 SL0090 SL0121 SL0082 SL0036 SL0035 SL0020 SL0019 SL0048 SL0021 SL0018 SL0043 SL0053 SL0055 SL0046 SL0038 SL0049 SL0127 SL0128 SL0104 SL0141 SL0056 SL0075 SL0106 SL0088 SL0117 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