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Recall Observatory FDA recall evidence

Device product

da Vinci Xi Surgical System

Z-1960-2020

November 21, 2018

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 84023
Status
Terminated
Classification
Class II
Quantity
74 USMs containing affected rotors.
Official record key
device-enforcement:Z-1960-2020

Official wording

Reason: 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.

Code information: Model: IS4000 UDI: 00886874114216 Device Listing: D215864 For System Name and USM Serial Numbers, refer to: ISIFA2018-15-C 806.10 Report_Affected Products List - Copy" files in Associated Documents.

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.