da Vinci X Surgical System, IS4200 - Product Usage: The da Vinci Xi surgical system (IS4000) is made of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the IS4000 system and its primary function is to su
Check against the official notice below — it lists the full affected range.
Intuitive Surgical Inc. is recalling Universal Surgical Manipulators (USMs) used in da Vinci Xi surgical systems due to high friction points that can cause the arm to experience increased resistance, hesitation, and jerking during use. The recall affects 270 USMs across 100 unique systems worldwide, including distribution throughout the United States and in Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom. The affected devices have specific serial numbers ranging from SL0085 to SL0369.
The source document does not specify a remedy or instructions for what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking.
Reason for recall: Failure of Universal Surgical Manipulators due to a high friction points, resulting in an increase of arm movement to include: feelings of resistance, hesitation, and jerking. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AZ, CA, CO, CT, District of Columbia, FL, GA, IL, IN, IA, KS. MA, MI, MS, NB, NY, OH, PA, TN, TX, VA, WA and WI and the countries of Australia, Belgium, Brazil, France, Germany, India, Italy, Japan, South Korea, Spain, Sweden, and the United Kingdom. Quantity: 270 USMs on a combination of 100 unique systems (4 USM per system) Lot/code info: UDI: 00886874114216 Device Listing: D295931 Serial Numbers: SL0085, SL0315, SL0317, SL0324, SL0338, SL0350, SL0351, SL0353, SL0354, SL0357, SL0369
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.