IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Enforcement
- Recall Number
- Z-0940-2015
- Event ID
- 69902
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intuitive Surgical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 14, 2015
- Initiation Date
- December 5, 2014
- Classification Date
- January 7, 2015
- Termination Date
- March 3, 2015
- Address
- 1266 Kifer Rd Bldg 100, N/A, Sunnyvale, CA, 94086-5304, United States
Description
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number 371683-05/Model Number VS3000 The Intuitive Surgical Endoscopic Instrument Control System (Intuitive Surgical da Vinci Surgical System Model IS3000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general cardiovascular and noncardiovascular thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures.
Intuitive Surgical is initiating a voluntary correction related to da Vinci Si System (IS3000) Vision Side Carts, with threaded-in caster wheels, which can result in the caster wheel bolts gradually unthreading and the wheels loosening.
Product number 371683-05/Model Number VS3000 Serial numbers - USA: SH0018, SH0057, SH0097, SH0132, SH0165, SH0235, SH0019, SH0058, SH0098, SH0133, SH0167, SH0248, SH0021, SH0059, SH0099, SH0134, SH0168, USG015, SH0024, SH0060, SH0100, SH0135, SH0169, USG072, SH0025,SH0064, SH0101, SH0136, SH0170, USG146, SH0026, SH0065, SH0102, SH0137,SH0171, USG213, SH0029, SH0066, SH0103, SH0138, SH0172, USG317, SH0030, SH0067, SH0104, SH0139, SH0175, USG352, SH0031, SH0068, SH0105, SH0140, SH0177, USG353, SH0032, SH0069, SH0106 ,SH0141, SH0179 ,USG445, SH0033, SH0070, SH0107, SH0142, SH0180, USG519, SH0035, SH0071, SH0109, SH0143, SH0182, USG559, SH0036, SH0072, SH0110, SH0144, SH0184, USG631,SH0038, SH0073, SH0112, SH0145, SH0185, USG700, SH0039, SH0076, SH0113, SH0146, SH0186, USG701,SH0040, SH0077, SH0115, SH0147, SH0187, USG702, SH0041, SH0078, SH0117, SH0149, SH0188 ,USG703, SH0042, SH0079, SH0118, SH0150, SH0189, USG721, SH0044, SH0080, SH0119, SH0151, SH0190 ,USG728, SH0045, SH0081, SH0120, SH0152, SH0194, USG748, SH0046, SH0082, SH0121, SH0153, SH0196, USG750, SH0047, SH0085, SH0123, SH0154, SH020,2 USG764, SH0048, SH0088, SH0124, SH0155, SH0203, USG769, SH0050, SH0089, SH0125, SH0156, SH0204, USG770, SH0051 SH0090 SH0126 SH0157 SH0206 USG775, SH0052, SH0091, SH0127, SH0158, SH0211, USG786, SH0053, SH0092, SH0128, SH0159, SH0215,, USG787, SH0054, SH0094, SH0129, SH0160, SH0216, USG788, SH0055, SH0095, SH0130, SH0163, SH0223, SH0056, SH0096, SH0131, SH0164, SH0224, Out of US: SH0034,USG217, SH0086, SH0087, SH0028,SH0084,SH0111, SH0191, USG754, SH0114, SH0116, SH0063, SH0148, USG484, USG727, SH0161, SH0162, SH0061, SH0093, SH0238, USG726, SH0062, SH0037, USG806.
Worldwide Distribution: US (nationwide) and countries of: Belgium, France, Germany, Romania, India, Israel, Italy, South Korea, Norway, Slovak Republic, Spain, Sweden, Turkey, and United Kingdom.
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