The da Vinci Xi Surgical System recall
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Why was The da Vinci Xi Surgical System recalled?
An Endoscope Controller has been improperly calibrated during manufacturing. This improper calibration may result in the Endoscope Controller showing surgical images that are dimmer, have color imbalance or have reduced fluorescence and grayscale when using Firefly. There is also potential for increased fogging of the endoscope.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
UDI Number: 00886874114193. Serial Number: SK1703.
- Product
- The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 1
- Distribution
- U.S.
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)