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Terminated

da Vinci Surgical System, IS 4000; Endoscope Controller, Model Number: 372601-16 (UDI: 00886874114193) is included in the IS 4000 Vision Cart, Model Number: 381121-31 (UDI 00886874110898) - Product Usage: used with an endoscope, surgical instruments, and accessories to perform minimally invasive surgical procedures.

FDA Recall Z-0283-2021 · Posted None

Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2019-06-17
Date Terminated2022-07-18
Product Quantity1 system

Reason for Recall

One da Vinci Xi Endoscope Controller in the field was improperly calibrated during servicing. The result of this improper calibration may result in the tip of the endoscope may reach higher temperature causing the potential for thermal tissue injury and/or overly bright images.

Firm Action

Send formal customer letter communication to the affected site. The firm reported that a representative scheduled an on-site visit to replace the affected unit.

Root Cause

Equipment maintenance

Distribution Pattern

US Nationwide distribution including in the state of Washington.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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