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

Recall Z-1305-2015 — GE Healthcare, SIGNA 1.5T TWINSPEED, SIGNA INFINITY MRISYSTEM, SIGNA 3.0T INFINITY WITH EXCITE, SIGNA 3.0T WITH EXCITE, SIGNA EXCITE 1.5T, SIGNA EXCITE 3.0T, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T, SIGNA Contour, Br

U.S. FDA — Device Enforcement · United States · 2015-03-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1305-2015
Date of alert: 2015-03-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: GE Healthcare
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 0910272012

Reported risk: GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.

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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