Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1718-2014 — Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da Vinci Surgical System IS 4000. The patient-side cart is positioned at the operating room table and contains four arms that are positioned over the target patient anatomy. The endoscope attaches onto any arm. The patient-sid

U.S. FDA — Device Enforcement · United States · 2014-05-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1718-2014
Date of alert
2014-05-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Reported risk: Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to over- or under-tightening of bolts that may result in system faults, mechanical sound (e.g. scraping, squeaking, rattling), cracks or vibration in the system.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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