da Vinci Xi Surgical System recall
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope…
Why was da Vinci Xi Surgical System 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Material number: 3680662-20: Serial numbers: 1311140273, 1311140370, 1311140385, 1311140148, 1311140099, 1311140152, 1311140081, 1311140473, 1311140561, 1311140409. Material number: 380662-21: Serial numbers: 1311140225, 1311140437, 1311140476, 1311140336, 1311140472, 1311140438, 1311140353, 1311140195, 1311140545, 1311140098 1311140189, 1311140465, 1311140394, 1311140366, 1311140008, 1311140115 1311140014, 1311140371, 1311140238, 1311140306, 1311140332, 1311140404 1311140054, 1311140188, 1311140324, 1311140453, 1311140408, 1311140237 1311140220, 1311140372, 1311140325, 1311140088, 1311140535, 1311140355.
- Product
- da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgical Endoscope…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 167 total da Vinci Xi affected systems
- Distribution
- 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.
- Recall date
- April 1, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)