CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report

da Vinci Si Surgical System IS3000 recalled by Intuitive Surgical

Intuitive Surgical is recalling da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a, distributed nationwide in the US. The recall was initiated on 17 Oct 2011 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesmodel numbers 380610-04 through 38-610-14.

Quantity recalled1,090 consoles

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-0088-2014
FDA event ID: 66434
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2011
FDA classified: 28 Oct 2013
Reported: 6 Nov 2013
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

17 Oct 2011	Recall initiated by company
28 Oct 2013	Classified by FDA	+742 days
6 Nov 2013	Published in enforcement report	+9 days

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

Reason for recall

Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.

Product as listed by the FDA

da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments.

Where it was distributed

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.

Nationwide Puerto Rico

Questions about this recall

Is da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a recalled?

Yes. Intuitive Surgical recalled da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a on 17 Oct 2011. The recall is Class II and its status is Terminated. Recall number Z-0088-2014.

Why was it recalled?

Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount.

Which lots are affected?

model numbers 380610-04 through 38-610-14.

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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