da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad
Medical device recall Z-1191-2016. Published in FDA’s Enforcement Report on Mar 30, 2016.
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 Mar 30, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 542 (351 SCC Touchpads and 191 PSC touchpads) 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?
FDA’s record gives no reason in a field of its own.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.
542 (351 SCC Touchpads and 191 PSC touchpads), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model # M187505-04 - IS3000/IS4000 SCC Touchpad: IS4000 PSC Touchpad. Serial numbers: SH2188 SK0391 SK0392 SK0454 SK0569 SK0577 SK0583 SK0613 SK0686 USG642 SK0482 SH0034 SH2321 SK0321 SK0426 SK0566 SK0603 SK0614 SH2312 SH2338 SH2339 SH2341…
Every code shown here, 1,998 characters
Model # M187505-04 - IS3000/IS4000 SCC Touchpad: IS4000 PSC Touchpad. Serial numbers: SH2188 SK0391 SK0392 SK0454 SK0569 SK0577 SK0583 SK0613 SK0686 USG642 SK0482 SH0034 SH2321 SK0321 SK0426 SK0566 SK0603 SK0614 SH2312 SH2338 SH2339 SH2341 SH2344 SH2360 SH2361 SH2362 SH0948 SH1104 SH2240 SK0648 SH2328 SH2329 SH2337 SH2342 SH2346 SH2350 SH2351 SH2352 SH2356 SH2363 SH2364 SH2365 SK0329 SK0588 SK0591 SK0428 SK0429 SK0453 SH0607 SH2340 SK0503 SK0598 SH0280 SH2331 SH2333 SH2345 SK0479 SK0499 SK0528 SK0567 SK0568 SK0584 USG122 SK0563 SK0576 SH1228 SK0447 SK0530 SK0670 SH0329 SH0881 SH2347 SH2348 SH2349 SK0089 SK0336 SK0395 SK0421 SK0517 SK0592 SK0593 SK0595 SK0596 SK0597 SH1802 SH2332 SK0305 SK0367 SK0374 SK0386 SK0388 SK0411 SK0424 SK0431 SK0462 SK0472 SK0473 SK0481 SK0520 SK0526 SK0575 SK0581 SK0586 SK0624 SK0639 SK0647 SH2318 SK0529 SK0335 SK0507 SK0632 SH0416 SK0611 SH2354 SK0460 SK0497 SK0381 SH1869 SK0405 SK0475 SK0510 SK0658 SK0407 SK0413 SK0540 SK0564 SK0565 SK0582 SK0315 SK0501 SH2313 SK0515 SK0580 SK0217 SK0318 SK0322 SH1380 SH2323 SH2326 SH2327 SH2359 SK0562 RSH0020 SD0003 SD0004 SD0005 SH0074 SH0164 SH0272 SH0473 SH0741 SH0934 SH0938 SH1011 SH1350 SH1356 SH1378 SH1394 SH1522 SH1983 SH2311 SH2315 SH2316 SH2320 SK0240 SK0281 SK0285 SK0299 SK0300 SK0301 SK0307 SK0309 SK0314 SK0317 SK0320 SK0331 SK0338 SK0339 SK0340 SK0342 SK0343 SK0346 SK0349 SK0352 SK0360 SK0372 SK0375 SK0376 SK0382 SK0383 SK0384 SK0385 SK0389 SK0390 SK0398 SK0400 SK0401 SK0402 SK0406 SK0408 SK0409 SK0412 SK0414 SK0415 SK0416 SK0417 SK0418 SK0419 SK0420 SK0423 SK0425 SK0430 SK0432 SK0433 SK0434 SK0435 SK0436 SK0437 SK0438 SK0439 SK0440 SK0441 SK0443 SK0444 SK0445 SK0446 SK0448 SK0449 SK0452 SK0455 SK0456 SK0457 SK0458 SK0459 SK0463 SK0464 SK0466 SK0467 SK0468 SK0471 SK0477 SK0478 SK0480 SK0483 SK0484 SK0485 SK0486 SK0487 SK0488 SK0489 SK0491 SK0492 SK0493 SK0494 SK0495 SK0496 SK0498 SK0500 SK0502 SK0504 SK0505 SK0506 SK0508 SK0511 SK0512 SK0513 SK0514 SK0516 SK0518 SK0519 SK0521 SK0522 SK0523…
FDA’s list runs to 2,516 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.
US and Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Israel, Italy, Japan, Malaysia, Monaco, Netherlands, Philippines, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, South Korea, Sweden, Switzerland, Taiwan, Turkey, United Kingdom and Venezuela.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Feb 16, 2016.
- FDA classified it on Mar 18, 2016.
- FDA’s Enforcement Report published it on Mar 30, 2016.
- FDA terminated it on Sep 21, 2016.
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 2,516 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.