Reported Aug 22, 2018 · Ongoing
The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- The da Vinci
- Xi Surgical System (IS4000) Model NameIS4000, Endoscope Controller
- Model Number372601-16
- Lot codes and dates
- UDI Number00886874114193
- Serial NumberSK1703
- Amount recalled
- 1
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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