Recall StatusOpen, Classified
Date Initiated2024-08-21
Product Quantity144
Reason for Recall
Surgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable Ergonomics: Viewer, headrest, armrest, and pedal tray position cannot be adjusted until da Vinci is restarted. Contact Technical Support to report the issue: Cancel-Disable" ergonomics locked until motor replaced; may lead to delay/aborted/alternate procedure
Firm Action
On 8/21/2024, correction notices were sent to customers who were informed of the following:
1) Share this notification with all personnel at your site who perform and support da Vinci procedures.
2) Inform affected personnel when the correction has been completed.
3) Complete and return the acknowledgement form via email to
[email protected]
4) Retain a copy of this letter and the acknowledgement form for your files.
5) Firm is actively working on making updated motor module assemblies available. Once available, an Intuitive representative will schedule a visit to replace the affected motor module sub-assembly.
If you need further information or support concerning this notification, please contact the firm's Customer Service: North and South America: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail:
[email protected]
Distribution Pattern
US Nationwide distribution in the states of MN, FL, CO, CA, NC, KS, TX, SC, WV, LA, OH, NY, NH, GA, KY, OK, NJ, MA, OR, PA, NM, AZ, TN, ND, IL, AR, WA, IN, VA, CT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.