FDA Device recall Z-2734-2015
da Vinci Xi Surgical System P4 software;with Xi Stapler
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of da Vinci Xi Surgical System P4 software;with Xi Stapler by Intuitive Surgical, citing complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2734-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-17 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci Xi Surgical System P4 software;with Xi Stapler; model number IS4000 : General and Plastic surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.
Reason
Complaints regarding the Exposed Knife Blade recoverable fault for the Xi Stapler with Xi System P4 version software.
Identifiers
| code_info | Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK…Model number IS4000; Affected da Vinci Xi Surgical System Serial Numbers SK0036 SK0076 SK0119 SK0156 SK0198 SK0250 SK0288 SK0342 SK0395 SK0425 SK0039 SK0077 SK0120 SK0157 SK0203 SK0254 SK0289 SK0346 SK0398 SK0433 SK0046 SK0079 SK0122 SK0159 SK0206 SK0255 SK0291 SK0347 SK0399 SK0434 SK0047 SK0081 SK0123 SK0160 SK0209 SK0257 SK0292 SK0352 SK0400 SK0437 SK0048 SK0087 SK0127 SK0161 SK0211 SK0259 SK0293 SK0356 SK0401 SK0440 SK0049 SK0091 SK0130 SK0162 SK0212 SK0262 SK0294 SK0358 SK0402 SK0441 SK0051 SK0092 SK0134 SK0163 SK0216 SK0263 SK0296 SK0359 SK0404 SK0443 SK0054 SK0093 SK0135 SK0167 SK0225 SK0264 SK0297 SK0360 SK0406 SK0445 SK0057 SK0095 SK0137 SK0168 SK0229 SK0265 SK0298 SK0366 SK0408 SK0448 SK0058 SK0096 SK0138 SK0169 SK0231 SK0266 SK0299 SK0371 SK0409 SK0451 SK0059 SK0098 SK0139 SK0171 SK0233 SK0267 SK0301 SK0375 SK0410 SK0452 SK0061 SK0099 SK0143 SK0173 SK0234 SK0269 SK0302 SK0376 SK0412 SK0455 SK0062 SK0100 SK0144 SK0175 SK0235 SK0270 SK0304 SK0378 SK0414 SK0456 SK0066 SK0101 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2734-2015%22
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