Intuitive Surgical, Inc. 2022-11-02 Health serious FDA
Health · FDA · Recall #FDA-Z-0133-2023
da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon… Recall
Issued November 2, 2022 · Intuitive Surgical, Inc.
In November 2022, Intuitive Surgical, Inc. recalled the da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Intuitive Surgical, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Intuitive Surgical, Inc.
- Category
- Health
- Recall date
- November 2, 2022
- Units affected
- Not reported
- Sold at
- 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 number
- FDA-Z-0133-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Intuitive Surgical, Inc. has 11 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.