Z-1960-2020 Class II Terminated
FDA device recall Z-1960-2020 was initiated by Intuitive Surgical, Inc. on Nov 21, 2018 and is designated Class II. 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. The recall status is terminated (terminated May 31, 2022). Affected quantity: 74 USMs containing affected rotors.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- Nov 21, 2018
- Termination Date
- May 31, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 74 USMs containing affected rotors.
Product Description
da Vinci Xi Surgical System
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.
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.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1960-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026