CLASS II Device recall · Reported 20 May 2020 · FDA Enforcement Report

da Vinci X Surgical System recalled by Intuitive Surgical

Intuitive Surgical is recalling da Vinci X Surgical System, distributed in 13 states. The recall was initiated on 21 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: IS4200 UDI: 00886874114216 Device Listing: D295931

Quantity recalled74 USMs containing affected rotors

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-1961-2020
FDA event ID: 84023
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 21 Nov 2018
FDA classified: 11 May 2020
Reported: 20 May 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

21 Nov 2018	Recall initiated by company
11 May 2020	Classified by FDA	+537 days
20 May 2020	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

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Product as listed by the FDA

da Vinci X Surgical System

Where it was distributed

U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.

California Delaware Florida Illinois Kentucky Massachusetts Maryland Michigan New Jersey New York Ohio Texas Virginia

Questions about this recall

Is da Vinci X Surgical System recalled?

Yes. Intuitive Surgical recalled da Vinci X Surgical System on 21 Nov 2018. The recall is Class II and its status is Terminated. Recall number Z-1961-2020.

Why was it recalled?

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Which lots are affected?

Model: IS4200 UDI: 00886874114216 Device Listing: D295931

Where was it sold?

U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan.

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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