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

Recall Z-1191-2016 — da Vinci Si (IS3000) and da Vinci Xi (IS4000) Surgeon Side Console (SSC)Touchpad; Model number 187505-04; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during ca

U.S. FDA — Device Enforcement · United States · 2016-02-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1191-2016
Date of alert: 2016-02-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intuitive Surgical, Inc.
Product category: device
Product type: Devices

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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