da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lam
FDA device recall Z-0146-2014 · posted 2013-11-04 · Terminated
Recall details
- Recalling firm
- Intuitive Surgical, Inc.
- Reason for recall
- Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors.
- Action taken
- Intuitive Surgical sent an Urgent Medical Device Correction letter dated October 23, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to open the illuminator and replace any metal-finish lamp modules with plastic finish lamp modules, if customers do not have a replacement plastic-finish lamp module available, they may continue to use the metal-finish lamp module until they receive a replacement. If the message "illuminator lamp module error: Please reseat or replace lamp module" is displayed on the patient side monitor and the surgeon console, contact intuitive Surgical Customer Service. Customers were also instructed to examine any remaining or spare inventory to identify any metal-finish lamp modules and return them to Intuitive Surgical for credit. Customers were instructed to ensure all affected personnel are fully informed of this Urgent Medical Device Corrrection letter. Customers should complete the attached Acknowledgement Form and return it to Intuitive Surgical as instructed. Customers with questions should contact Intuitive Surgical Customer Service. For questions regarding this recall call 408-523-2244.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NAY
- Quantity affected
- Standalone: 161 units; With Vision Starter Kit: 240 units; With IS3000 Vision Cart: 283 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Brazil, *Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, I
- Date initiated
- 2013-10-21
- Date posted
- 2013-11-04
- Date terminated
- 2014-09-04
- 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 |
|---|---|---|
| INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 (K081137) | Intuitive Surgical, Inc. | 2009-02-18 |