The da Vinci Xi Surgical System (IS4000) Model Name: IS4000, Endoscope Controller. Model Number: 372601-16.
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling one da Vinci Xi Surgical System Endoscope Controller (Model IS4000, Model Number 372601-16, Serial Number SK1703) due to improper calibration during manufacturing. The affected device may display surgical images that are dimmer than normal, show color imbalance, or have reduced fluorescence and grayscale imaging when using the Firefly feature. The device may also experience increased fogging of the endoscope.
The recalled Endoscope Controller was distributed in the United States and can be identified by its UDI Number 00886874114193 and Serial Number SK1703. The recall notice does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: U.S. Quantity: 1 Lot/code info: UDI Number: 00886874114193. Serial Number: SK1703.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.