Intuitive Surgical Recalls da Vinci Xi Endoscope Controller for Calibration Defect
Intuitive Surgical is recalling one da Vinci Xi Endoscope Controller due to improper calibration. The defect may cause dim images, color imbalance, or increased fogging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves image quality degradation (dimness, color imbalance, fogging) which is a functional defect but does not involve direct physical injury, death, or high-risk pathogens, fitting the Moderate category for low-risk contamination or functional issues without reported harm.
Plain-English summary
Intuitive Surgical, Inc. is recalling one unit of the da Vinci Xi Surgical System (IS4000) Endoscope Controller (Model Number: 372601-16). The recall is limited to a specific unit identified by UDI Number 00886874114193 and Serial Number SK1703.
The recall was initiated because the Endoscope Controller was improperly calibrated during manufacturing. This defect may result in the device displaying surgical images that are dimmer, have color imbalance, or have reduced fluorescence and grayscale when using Firefly. Additionally, there is a potential for increased fogging of the endoscope.
The affected product was distributed in the U.S. Intuitive Surgical, Inc. is the recalling firm. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice itself.
The recalled product
- Product
- The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Surgical System
- Affected units
- 1
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 (1)
- UDI Number: 00886874114193. Serial Number: SK1703.
Distribution
Distribution scope not specified by the agency.
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