da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope,…
Medical device recall Z-0926-2020. Published in FDA’s Enforcement Report on Feb 12, 2020.
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 Feb 12, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 33 states named
- 52 surgical 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?
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.
52 surgical systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
System Serial # PSC Serial # VSC Serial # SL0350 665033 Not Affected SL0360 292201 Not Affected SL0361 Not Affected 1000216 SL0362 381021 678362 SL0365 34608 Not Affected SL0366 Not Affected 1000217 SL0369 Not Affected 679520 SL0370 Not…
Every code shown here, 1,286 characters
System Serial # PSC Serial # VSC Serial # SL0350 665033 Not Affected SL0360 292201 Not Affected SL0361 Not Affected 1000216 SL0362 381021 678362 SL0365 34608 Not Affected SL0366 Not Affected 1000217 SL0369 Not Affected 679520 SL0370 Not Affected 678840 SL0371 Not Affected 305493 SL0372 415418 678699 SL0373 429524 334972 SL0375 332395 678509 SL0376 Not Affected 680721 SL0377 Not Affected 991369 SL0378 266528 872469 SL0379 311710 676421 SL0380 Not Affected 268852 SL0385 Not Affected 304487 SL0386 62043 681143 SL0387 308179 687814 SL0388 Not Affected 688819 SL0389 71796 308181 SL0391 518359 285588 SL0392 Not Affected 685499 SL0393 295941 687813 SL0394 281121 687293 SL0395 43875 689242 SL0396 Not Affected 685077 SL0397 892731 685500 SL0398 Not Affected 330718 SL0399 Not Affected 685080 SL0400 492489 769792 SL0401 292512 682912 SL0402 Not Affected 682536 SL0403 Not Affected 688818 SL0404 278656 691238 SL0406 680584 324350 SL0407 Not Affected 688038 SL0408 81482 331850 SL0409 Not Affected 691236 SL0410 768663 Not Affected SL0411 685403 695335 SL0412 Not Affected 692045 SL0413 Not Affected 698304 SL0415 870352 699139 SL0416 Not Affected 343215 SL0417 697081 692043 SL0418 268716 694230 SL0419 264189 697313 SL0420 279659 699148 SL0423 291981 260861 SL0424 Not Affected 683692
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 distribution in the states of Alabama, Alaska, Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Montana, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Texas, Virginia, Washington, West Virginia, Wisconsin and countries of Belgium, Brazil, France, Germany, India, Ireland, Italy, Japan, Norway, Panama, Poland, South Korea, Spain, Taiwan, and United Kingdom
The states and territories these words name
33 states and territories.
Every one of them
- Alaska
- Alabama
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Hawaii
- Iowa
- Idaho
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- New Jersey
- New Mexico
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
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 26, 2019.
- FDA classified it on Jan 31, 2020.
- FDA’s Enforcement Report published it on Feb 12, 2020.
- FDA terminated it on Aug 10, 2022.
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.”
- 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
-
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.