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

Recall Z-3254-2018 — da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasive surgery. All three

U.S. FDA — Device Enforcement · United States · 2018-07-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3254-2018
Date of alert: 2018-07-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Intuitive Surgical, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00886874110744

Reported risk: Certain Redundant Medical Grade Power Supply (RMGPS) units specific to Surgeon Console and Patient Side Carts were manufactured incorrectly and may fail prior or during use.

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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