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

Recall Z-1431-2018 — Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

U.S. FDA — Device Enforcement · United States · 2018-03-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1431-2018
Date of alert: 2018-03-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Philips Electronics North America Corporation
Product category: device
Product type: Devices

Reported risk: Potential risk for helium gas inside the MR examination room during a magnet quench

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.

Recall Z-1431-2018 — Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body,or extremities.

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