Reported Jan 14, 2015 · Terminated
IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 100 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- 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.
- Lot codes and dates
- Product number 371683-05/Model
- Number VS3000 Serial numbers - USA
173 of 173 codes
SH0018SH0057SH0097SH0132SH0165SH0235SH0019SH0058SH0098SH0133SH0167SH0248SH0021SH0059SH0099SH0134SH0168USG015SH0024SH0060SH0100SH0135SH0169USG072SH0025SH0064SH0101SH0136SH0170USG146SH0026SH0065SH0102SH0137SH0171USG213SH0029SH0066SH0103SH0138SH0172USG317SH0030SH0067SH0104SH0139SH0175USG352SH0031SH0068SH0105SH0140SH0177USG353SH0032SH0069SH0106SH0141SH0179USG445
- Out of US
SH0034USG217SH0086SH0087SH0028SH0084SH0111SH0191USG754SH0114SH0116SH0063SH0148USG484USG727SH0161SH0162SH0061SH0093SH0238USG726SH0062SH0037USG806
- Amount recalled
- 202
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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