Recall Z-2521-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
Da Vinci ASSY, PSS, SP1098, Part Number: 380601
| Date | Jun 22, 2026 (initiated Apr 22, 2026) |
| Status | Open, Classified |
| Reason | Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding. |
| Root cause | Process control |
| Action | On 4/22/2026, correction notices were mailed and emailed to customers who were asked to do the following: 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep a copy of the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. A firm Representative will schedule a site visit to p |
| Quantity | 454 |
| Distribution | Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Swit |
| FDA record | Open on fda.gov |