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

Recall Z-0323-2017 — Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The visualization stylet is cons

U.S. FDA — Device Enforcement · United States · 2016-09-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0323-2017
Date of alert: 2016-09-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Medtronic Navigation, Inc.
Product category: device
Product type: Devices

Reported risk: Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.

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

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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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