FDA Device recall Z-1191-2016
da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad
- FDA Device
- Class II
- terminated
- Published 2016-03-30
On 2016-03-30 the FDA classified a Class II recall of da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad by Intuitive Surgical.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1191-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-03-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Intuitive Surgical |
| Distribution | n/a |
Product
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.
Reason
Identifiers
| code_info | Model # M187505-04 - IS3000/IS4000 SCC Touchpad: IS4000 PSC Touchpad. Serial numbers: SH2188 SK0391 SK0392 SK0454…Model # M187505-04 - IS3000/IS4000 SCC Touchpad: IS4000 PSC Touchpad. Serial numbers: 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 SK0568 SK0584 USG122 SK0563 SK0576 SH1228 SK0447 SK0530 SK0670 SH0329 SH0881 SH2347 SH2348 SH2349 SK0089 SK0336 SK0395 SK0421 SK0517 SK0592 SK0593 SK0595 SK0596 SK0597 SH1802 SH2332 SK0305 SK0367 SK0374 SK0386 SK0388 SK0411 SK0424 SK0431 SK0462 SK0472 SK0473 SK0481 SK0520 SK0526 SK0575 SK0581 SK0586 SK0624 SK0639 SK0647 SH2318 SK0529 SK0335 SK0507 SK0632 SH0416 SK0611 SH2354 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1191-2016%22
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