Intuitive Surgical Recalls da Vinci Xi Systems Due to Sensor Fault
Intuitive Surgical is recalling 167 da Vinci Xi Surgical Systems worldwide because a fault causes distal SUJ failures and position sensor mismatches.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a mechanical fault could compromise surgical accuracy, but the source text does not report any injuries, illnesses, or fatalities, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Intuitive Surgical, Inc. is recalling 167 da Vinci Xi Surgical Systems (Model IS4000) due to a fault that causes distal SUJ (DSUJ) failures. The issue indicates a mismatch between the positions reported by the redundant position sensors on one of the patient cart arm joints.
The affected components are the ASSY, DISTAL SUJ, OUTER, IS4000, with material numbers 380663-20 and 380663-21. The recall covers systems distributed in the United States and internationally, including Australia, Belgium, China, France, Germany, India, Israel, Italy, Norway, South Korea, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.
The da Vinci Surgical System is intended to assist in the accurate control of Intuitive Surgical Endocopic Instruments during various surgical procedures, including urologic, general laparoscopic, gynecologic, and thorascopic procedures. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- 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 Surgic
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 167
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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