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

Recall Z-1435-2018 — Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781196, 4) Achieva 1.5T Conversion Model 781283, 5) Achieva 1.5T Model 781296, 6) Achieva 1.5T R5 based Model 781343, 7) Achieva 1.5T Conversion R5 based Model 781346 & 8) Achieva 1.

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-1435-2018
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.

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