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

SIGNA Creator, SIGNA ExplorerProduct Usage: 1.5T SIGNA Creator and 1.5T SIGNA Explorer is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, — recall Z-3026-2017

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-3026-2017
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.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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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