Reported Mar 30, 2016 · Terminated

da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to…

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 100 · Sunnyvale, CA · 94086-5304

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.

Lot codes and dates: Model #
M187505-04 - IS3000/IS4000 SCC TouchpadIS4000 PSC Touchpad
Serial numbers
347 of 347 codes
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
Amount recalled: 542 (351 SCC Touchpads and 191 PSC touchpads)

The notice does not describe the hazard.

This product could cause temporary or reversible health problems — stop using it.

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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89 in total.