da Vinci Xi Surgical System
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling 74 da Vinci Xi Surgical Systems (Model IS4000) distributed in the United States and internationally due to a manufacturing variation in the arm. This defect can cause a persistent recoverable fault error (error 23087) that results in loss of arm functionality either before or during surgery. The affected systems are located in California, Maryland, New York, Virginia, Illinois, Michigan, Delaware, Texas, Florida, New Jersey, Massachusetts, Kentucky, Ohio, as well as Australia, France, Germany, and Japan.
The source document does not specify a remedy or what affected consumers should do in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: U.S.: CA, MD, NY, VA, IL, MI, DE, TX, FL, NJ, MA, KY and OH. O.U.S.: Australia, France, Germany and Japan. Quantity: 74 USMs containing affected rotors. Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.