CLASS II Device recall · Reported 1 Apr 2015 · FDA Enforcement Report

da Vinci Xi Surgical System, IS4000 recalled by Intuitive Surgical

Intuitive Surgical is recalling da Vinci Xi Surgical System, IS4000, distributed nationwide in the US. The recall was initiated on 3 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial number: 380647-20; Serial numbers: 1311140430, 1311140586, 1311140058, 1311140392. 1311140277, 1311140307, 1311140094, 1311140100, 1311140569, 1311140102, 1311140421, 1311140092, 1311140009, 1311140070, 1311140267, 1311140333, 1311140492, 1311140391, 1311140057, 1311140294, 1311140508, 1311140565, 1311140105, 1311140122, 1311140469, 1311140521, 1311140378, 1311140456, 1311140230 1311140573, 1311140065, 1311140164, 1311140194, 1311140511, 1311140291, 1311140304, 1311140212, 1311140222, 1311140001, 1311140137, 1311140344, 1311140381, 1311140341, 1311140538, 1311140168, 1311140523, 1311140274, 1311140033, 1311140091 1311140248, 1311140141, 1311140436, 1311140418, 1311140548 1311140320, 1311140170, 1311140346. Material number 380746-22: Serial numbers: 1311140486 1311140539, 1311140174, 1311140183, 1311140327, 1311140347 1311140482, 1311140145, 1311140066, 1311140302, 1311140477 1311140084, 1311140211, 1311140103, 1311140083, 1311140050, 1311140488, 1311140365, 1311140207, 1311140459, 1311140557, 1311140423, 1311140045, 1311140440, 1311140231.

Quantity recalled167 total affected da Vinci Xi systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1304-2015
FDA event ID: 70705
Recalling firm: Intuitive Surgical, Sunnyvale, CA
Classification: Class II
Status: Terminated
Recall initiated: 3 Mar 2015
FDA classified: 20 Mar 2015
Reported: 1 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

3 Mar 2015	Recall initiated by company
20 Mar 2015	Classified by FDA	+17 days
1 Apr 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endscopic retractors, electrocautery and accessories for edoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximations, ligation, electrocautery, suturing and delivery and placement of microware and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic labaroscopic surgical procedures, general thorascopic surgical procedures and thorascopically-assisted cardiotomy procedures.

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and United Kingdom.

Nationwide

Questions about this recall

Is da Vinci Xi Surgical System, IS4000 recalled?

Yes. Intuitive Surgical recalled da Vinci Xi Surgical System, IS4000 on 3 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1304-2015.

Why was it recalled?

Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.

Which lots are affected?

Material number: 380647-20; Serial numbers: 1311140430, 1311140586, 1311140058, 1311140392. 1311140277, 1311140307, 1311140094, 1311140100, 1311140569, 1311140102, 1311140421, 1311140092, 1311140009, 1311140070, 1311140267, 1311140333, 1311140492, 1311140391, 1311140057, 1311140294, 1311140508, 1311140565, 1311140105, 1311140122, 1311140469, 1311140521, 1311140378, 1311140456, 1311140230 1311140573, 1311140065, 1311140164, 1311140194, 1311140511, 1311140291, 1311140304, 1311140212, 1311140222, 1311140001, 1311140137, 1311140344, 1311140381, 1311140341, 1311140538, 1311140168, 1311140523, 1311140274, 1311140033, 1311140091 1311140248, 1311140141, 1311140436, 1311140418, 1311140548 1311140320, 1311140170, 1311140346. Material number 380746-22: Serial numbers: 1311140486 1311140539, 1311140174, 1311140183, 1311140327, 1311140347 1311140482, 1311140145, 1311140066, 1311140302, 1311140477 1311140084, 1311140211, 1311140103, 1311140083, 1311140050, 1311140488, 1311140365, 1311140207, 1311140459, 1311140557, 1311140423, 1311140045, 1311140440, 1311140231.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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