FDA Device recall Z-1303-2015
da Vinci Xi Surgical System, IS4000
- FDA Device
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of da Vinci Xi Surgical System, IS4000 by Intuitive Surgical, citing 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 c….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1303-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-03 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. 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.
Reason
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.
Identifiers
| code_info | Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424, 1311140196, 1311140146,…Material number: 380663-20; Serial numbers: 1311140532, 1311140035, 1311140475, 1311140424, 1311140196, 1311140146, 1311140252, 1311140010, 1311140289, 1311140578, 1311140435, 1311140349, 1311140411, 1311140389, 1311140156, 1311140198, 1311140452, 1311140186, 1311140554 1311140335, 1311140249. Material number 380663-21: Serial numbers: 1311140047, 1311140541, 1311140181, 1311140352 1311140023, 1311140165, 1311140159, 1311140126, 1311140571, 1311140397, 1311140130, 1311140318, 1311140180, 1311140151 1311140375, 1311140428, 1311140528, 1311140263, 1311140169 1311140443, 1311140537, 1311140544, 1311140419, 1311140006 1311140583, 1311140173, 1311140154. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1303-2015%22
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