Z-0940-2015Class II

IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number...

Name: Z-0940-2015 IS3000 Vision Side Cart (VSC) used in conjunction with the da Vinci Si Surgical System IS3000. Product number...
Creator: Intuitive Surgical, Inc.
Published: 2014-12-05
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-12-05 / Terminated / root cause: design

FDA source

Intuitive Surgical, Inc. began a recall of 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... on 2014-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0940-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-05
Posted: 2015-01-07
Terminated: 2015-03-03
Recalling firm: Intuitive Surgical, Inc.
Product: 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.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Intuitive Surgical, sent an "Urgent Medical Device Correction" letter dated December 5, 2014 to all customers on December 5, 2014 by trackable method. The letter described the product, problem and actions to be taken. The customers were instructed to: ensure all affected personnel are fully informed of this notice; identify affected product, and retain a copy of this notice with your da Vinci Si user manual. Please note: the da Vinci Si Vision Side Cart can continue to be used safely. Ensure that all wheels are fully unlocked before attempting to move the Vision Side Cart. Avoid rolling the Vision Side Cart over uneven surfaces (i.e., over cables or a threshold). Intuitive Surgical is working on a newly designed wheel assembly. Upon availability, Field Service will retrofit the wheel assembly of the affected Vision Side Carts with the new design. If you need further information or support concerning this Medical Device Correction, please contact your Clinical Sales Representative or Intuitive Surgical Customer Service at the numbers listed below: North America and South America: 8008761310 Option 3 (6 a.m. to 5 p.m. PST) Japan: 0120565635 or 0355751362 (9 a.m. to 6 p.m. JST) South Korea: 0232713200 (9 a.m. to 6 p.m. KST) Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 a.m. to 6 p.m.) or [email protected]
Quantity in commerce: 202
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0940-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0940-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-07

Product code NAY

K081137Class IIIntuitive Surgical Da Vinci Si Surgical System: Model Is3000Intuitive Surgical, Inc. / cleared 2009-02-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)