Z-1718-2014Class II

Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000...

Name: Z-1718-2014 Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000...
Creator: Intuitive Surgical, Inc.
Published: 2014-05-09
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2014-05-09 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating... on 2014-05-09. FDA classified it as Class II and gives the reason as "Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1718-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-09
Posted: 2014-06-04
Terminated: 2014-06-04
Recalling firm: Intuitive Surgical, Inc.
Product: Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-side assistant attaches/detaches the endoscope and instrument intra-operatively.
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intuitive sent an Urgent Medical Device Correction letter dated May 13, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. All personnel who use the device should be notified of the issue and the acknowledgement form completed and returned. Intuitive reps will visit each affect sites to install a replacement PSC and ensure that it is properly integrated with the Da Vinci. For questions contact Intuitive Surgical at 800-876-1310 Option 3 (Monday - Friday 6 am to 5 pm PST).
Quantity in commerce: 2
Distribution: Medical facilities in TX and FL
Product codes and lots: lot 380652-20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1718-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1718-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-04

Product code NAY

K131861Class IIDa Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. / cleared 2014-03-28

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)