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

Recall Z-0275-2022 — The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera

U.S. FDA — Device Enforcement · United States · 2021-09-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0275-2022
Date of alert: 2021-09-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intuitive Surgical, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00886874112199

Reported risk: Incorrect expiration date on its package labeling (shipper box and inner carton label).

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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