CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report

da Vinci Si Surgeon Console recalled by Intuitive Surgical

Intuitive Surgical is recalling da Vinci Si Surgeon Console, distributed nationwide in the US. The recall was initiated on 19 Sep 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number: 314850, versions 1-6

Quantity recalledNA

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1429-2013
FDA event ID: 65083
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2011
FDA classified: 29 May 2013
Reported: 5 Jun 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

19 Sep 2011	Recall initiated by company
29 May 2013	Classified by FDA	+618 days
5 Jun 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Clarification of existing labeling information and operating procedures.

Product as listed by the FDA

da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.

Where it was distributed

Worldwide Distribution- USA Nationwide and countries of: Argentina, Australia,Canada, Chile, China, Czech Republic, Egypt, India, Israel, Italy,Korea-Republic of, Poland, Qatar, Romania, Saudi Arabia, Singapore, Spain, Thailand, Turkey, and Venezuela.

Nationwide

Questions about this recall

Is da Vinci Si Surgeon Console recalled?

Yes. Intuitive Surgical recalled da Vinci Si Surgeon Console on 19 Sep 2011. The recall is Class II and its status is Terminated. Recall number Z-1429-2013.

Why was it recalled?

Clarification of existing labeling information and operating procedures.

Which lots are affected?

Model number: 314850, versions 1-6

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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