da Vinci X Surgical System
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. recalled 74 da Vinci X Surgical Systems (Model IS4200) due to a manufacturing variation in the arm that can cause a persistent recoverable fault error (error 23087) and loss of arm functionality before or during surgery. The affected units were distributed in the United States across California, Maryland, New York, Virginia, Illinois, Michigan, Delaware, Texas, Florida, New Jersey, Massachusetts, Kentucky, and Ohio, as well as internationally in Australia, France, Germany, and Japan.
The recall record 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: IS4200 UDI: 00886874114216 Device Listing: D295931
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.