Z-1896-2020 Class II Terminated
Recalled by Intuitive Surgical Inc
— Sunnyvale, CA
FDA device recall Z-1896-2020 was initiated by Intuitive Surgical Inc on April 11, 2019 and is designated Class II. 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. The recall status is terminated (terminated April 8, 2024). Affected quantity: 270 USM units on a combination of 100 unique systems.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- April 11, 2019
- Termination Date
- April 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 270 USM units on a combination of 100 unique systems
Product Description
da Vinci Xi Surgical System, IS4000 - 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 support the instrument arms and camera arm. The system has four Universal Surgical Manipulators (USM) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. There are 4 USM per da Vinci Xi surgical system.
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 Pattern
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.
Code Information
UDI: 00886874114216 Device Listing: D215864 Serial Numbers: SK0736, SK0856, SK1318, SK1943, SK2228, SK2236, SK2239, SK2240, SK2242, SK2244, SK2248, SK2251, SK2255, SK2256, SK2259, SK2260, SK2261, SK2266, SK2269, SK2270, SK2274, SK2275, SK2281, SK2283, SK2285, SK2294, SK2295, SK2297, SK2300, SK2303, SK2304, SK2305, SK2310, SK2311, SK2312, SK2313, SK2314, SK2315, SK2317, SK2318, SK2320, SK2327, SK2329, SK2330, SK2331, SK2333, SK2341, SK2342, SK2343, SK2346, SK2348, SK2349, SK2350, SK2353, SK2355, SK2356, SK2358, SK2359, SK2360, SK2362, SK2363, SK2364, SK2365, SK2367, SK2368, SK2369, SK2370, SK2373, SK2374, SK2375, SK2383, SK2385, SK2389, SK2390, SK2393, SK2397, SK2402, SK2404, SK2405, SK2406, SK2412, SK2418, SK2420, SK2437, SK2449, SK2451, SK2452, SK2453, SK2455