Brand Name: Da Vinci 5 Product Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals Model/Catalog Number: 380730 Software Vers
FDA device recall Z-1325-2025 · posted 2025-03-12 · Open, Classified
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed
- Action taken
- On February 26, 2025, Intuitive Surgical issued a Urgent: Medical Device Correction to affected consignees via E-Mail. Intuitive asked consignees to take the following actions: 1. Read and understand this notification. 2. Share this notification with all personnel at your site who perform and support da Vinci procedures. 3. Inform affected personnel when the correction has been completed. 4. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. 5. Please retain a copy of this letter and the acknowledgement form for your files. 6. Please inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject devices via the standard complaint process 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 8. Complete and submit the report Online Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. An Intuitive representative will schedule a visit to replace the affected foot tray assembly.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- NAY
- Quantity affected
- 439 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kent
- Date initiated
- 2025-02-26
- Date posted
- 2025-03-12
- 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 Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation (K232610) | Intuitive Surgical, Inc. | 2024-03-14 |