Intuitive Surgical, Inc. Recall: da Vinci X (IS4200) and Xi (IS4000) systems, which consis
Intuitive Surgical, Inc. Recall: da Vinci X (IS4200) and Xi (IS4000) systems, which consis is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Intuitive Surgical, Inc.; Product: da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient C
| Recalling firm | Intuitive Surgical, Inc. |
|---|---|
| Product | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision System (VSS) |
| Reason for recall | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3) Yellow pedal associated with force bipolar is pressed, released with head in surgeon console 4) Blue pedal associated with bipolar is pressed, resulting in force bipolar energy delivery |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD, TX, IA, MA, NE, AZ, WA, CO, AL, SC |
| Recall initiated | 20220920 |
| Recall number | Z-0133-2023 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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