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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Intuitive Surgical, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0926-2020
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