da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSC
FDA device recall Z-0133-2023 · posted 2022-10-25 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- 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
- Action taken
- On 09/20/22, correction notices were mailed to customers. Customers were advised of the following: 1) The system software version can be located on the Vision Cart Touchscreen in the Troubleshooting Tab. 2) Ensure all device users read and understand this notice. 3) Notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4) Ensure proper instrument connections to the generator(s) and continue to follow all existing warnings and cautions found in user manuals 551400-15, USER MANUAL,SYS,P10,US,IS4000, 553873-07, USER MANUAL,I-A,MDR P10,IS4000-IS4200 and 554070-04, ADD,I-A,FORCE BIPOLAR,IS4000,IS4200. 5) Complete and return the acknowledgement form. 6) The recalling firm will follow-up with customers and schedule a software upgrade. 7) After the upgrade, inform all personnel that the software update/upgrade was completed. 8) If you have experienced this issue or require additional assistance, contact Technical Support: 800-876-1310, Option 1 (24/7) or customerservice@intusurg.com
- Root cause
- Software Design Change
- Status
- Open, Classified
- Product code
- NAY
- Quantity affected
- 162
- 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
- Date initiated
- 2022-09-20
- Date posted
- 2022-10-25
- Location
- Sunnyvale, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| da Vinci X Surgical System (K171294) | Intuitive Surgical, Inc. | 2017-05-26 |
| DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES (K131861) | Intuitive Surgical, Inc. | 2014-03-28 |