Reported Feb 12, 2020 · Terminated
da Vinci X Surgical System Surgical System, IS4200, 00886874114216 Product Usage: used with an endoscope, surgical…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
da Vinci X Surgical System Surgical SystemIS420000886874114216
- Product Usageused with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures
- Lot codes and dates
- 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 AffectedNot Affected 680721 SL0377 Not Affected
305493SL0372415418678699SL0373429524334972SL0375332395678509SL0376
Not Affected 268852 SL0385 Not Affected991369SL0378266528872469SL0379311710676421SL0380
Not Affected304487SL038662043681143SL0387308179687814SL0388
Not Affected688819SL038971796308181SL0391518359285588SL0392
Not Affected 685077 SL0397 892731 685500 SL0398 Not Affected 330718 SL0399 Not Affected685499SL0393295941687813SL0394281121687293SL039543875689242SL0396
Not Affected 682536 SL0403 Not Affected685080SL0400492489769792SL0401292512682912SL0402
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 Affected688818SL0404278656691238SL0406680584324350SL0407
Not Affected 683692343215SL0417697081692043SL0418268716694230SL0419264189697313SL0420279659699148SL0423291981260861SL0424
- 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
- Amount recalled
- 52 surgical systems
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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