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

Recall Z-3027-2017 — 1.5T Signa HDx, 3.0T Signa HDx, 1.5T Signa HDxt, 3.0T Signa HDxt, Signa HDi, Signa Vibrant Product Usage: The GE Signa¿ HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa¿ HDx MR system is indi

U.S. FDA — Device Enforcement · United States · 2017-05-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3027-2017
Date of alert: 2017-05-11
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Medical Systems, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840682115971

Reported risk: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

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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