CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

da Vinci X Surgical System Surgical System, IS4200 recalled

Intuitive Surgical is recalling da Vinci X Surgical System Surgical System, IS4200, 00886874114216, distributed nationwide in the US. The recall was initiated on 26 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem 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

Quantity recalled52 surgical systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0926-2020
FDA event ID: 84335
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 26 Jul 2019
FDA classified: 31 Jan 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

26 Jul 2019	Recall initiated by company
31 Jan 2020	Classified by FDA	+189 days
12 Feb 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Alaska Alabama Arizona California Colorado Connecticut Florida Hawaii Iowa Idaho Illinois Kansas Kentucky Louisiana Massachusetts Michigan Minnesota Missouri Montana North Carolina

Questions about this recall

Is da Vinci X Surgical System Surgical System, IS4200, 00886874114216 recalled?

Yes. Intuitive Surgical recalled da Vinci X Surgical System Surgical System, IS4200, 00886874114216 on 26 Jul 2019. The recall is Class II and its status is Terminated. Recall number Z-0926-2020.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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