da Vinci Si Surgical System IS3000 with the da Vinci recall
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the…
Why was da Vinci Si Surgical System IS3000 with the da Vinci recalled?
Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
model numbers 380610-04 through 38-610-14.
- Product
- da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1,090 consoles
- Distribution
- Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, Chile, China, Denmark, Egypt, Finland, France, Greece, Germany, India, Indonesia, Israel, Ireland, Italy, Kuwait, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Kingdom.
- Recall date
- November 6, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)