da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System…
Medical device recall Z-3254-2018. Published in FDA’s Enforcement Report on Oct 3, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 3, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1,014 currently installed on systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
1,014 currently installed on systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 2,000 characters
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 SL0134 SL0122 SL0158 SL0158 SL0120 SL0118 SL0135 SL0124 SL0125 da Vinci Xi Surgical System IS4000 00886874110690 00886874110713 System/Console Name/Number: SK0241 SK1145 SK1143 SK1151 SK1151 SK1291 SK1186 SK1292 SK1297 SK1292 SK1449 SK0583 SK0312 SK1090 SK1185 SK1191 SK1521 SK1521 SK1554 SK1226 SK1306 SK1304 SK1683 SK1734 SK1423 SK1601 SK1602 SK1421 SD0009 SK1149 SK1147 SK0972 SK1327 SK1743 SK1743 SK1747 SK1083 SK1083 SK1252 SK1378 SK1252 SK1325 SK1173 SK1178 SK1173 SK1360 SK1179 SK1325…
FDA’s list runs to 7,410 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jul 16, 2018.
- FDA classified it on Sep 26, 2018.
- FDA’s Enforcement Report published it on Oct 3, 2018.
- FDA terminated it on Oct 5, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Intuitive Surgical, Inc., of Sunnyvale, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,410 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.