IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/
FDA device recall Z-0940-2015 · posted 2015-01-07 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
- Action taken
- The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated December 5, 2014 to all customers on December 5, 2014 by trackable method. The letter described the product, problem and actions to be taken. The customers were instructed to: ensure all affected personnel are fully informed of this notice; identify affected product, and retain a copy of this notice with your da Vinci Si user manual. Please note: the da Vinci Si Vision Side Cart can continue to be used safely. Ensure that all wheels are fully unlocked before attempting to move the Vision Side Cart. Avoid rolling the Vision Side Cart over uneven surfaces (i.e., over cables or a threshold). Intuitive Surgical is working on a newly designed wheel assembly. Upon availability, Field Service will retrofit the wheel assembly of the affected Vision Side Carts with the new design. If you need further information or support concerning this Medical Device Correction, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at the numbers listed below: North America and South America: 8008761310 Option 3 (6 a.m. to 5 p.m. PST) Japan: 0120565635 or 0355751362 (9 a.m. to 6 p.m. JST) South Korea: 0232713200 (9 a.m. to 6 p.m. KST) Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 a.m. to 6 p.m.) or ics@intusurg.com
- Root cause
- Device Design
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- 202
- Distribution
- Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom.
- Date initiated
- 2014-12-05
- Date posted
- 2015-01-07
- Date terminated
- 2015-03-03
- Location
- Sunnyvale, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |