International safety notice

Urgent Field Safety Notice for Sagittal VIBRANT with NoSlabWrap factor greater than 1.0. SIGNA Premier, SIGNA Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA Voyager, Optima MR450w 1.5T, SIGNA Artist, SIGNA Creator, SIGNA Explorer, by GE Healthcare Clinical Systems

Germany / BfArM · DEU · Sep 22, 2021

Key facts

Title Urgent Field Safety Notice for Sagittal VIBRANT with NoSlabWrap factor greater than 1.0. SIGNA Premier, SIGNA Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA Voyager, Optima MR450w 1.5T, SIGNA Artist, SIGNA Creator, SIGNA Explorer, by GE Healthcare Clinical Systems
Regulator Germany / BfArM
Country DEU
Brand Sagittal VIBRANT with NoSlabWrap factor greater than 1.0. SIGNA Premier, SIGNA Pioneer, SIGNA Architect, Discovery MR750w 3.0T, Discovery MR750 3.0T, SIGNA Voyager, Optima MR450w 1.5T, SIGNA Artist, SIGNA Creator, SIGNA Explorer,
Manufacturer GE Healthcare Clinical Systems
Models MR450W, 00840682115971, 00195278126443, 00195278210036, 00840682123457, 00840682113786, PX26.4, 00840682144261, RX27.3, 00840682146104, MR750W, SV25.4 and 34 more
Date Sep 22, 2021
Regulator page bfarm.de

At a glance

  • No Recall
  • No Field safety notice
  • 1–9 Matching device models in FDA data
  • 1–9 Matching catalog numbers in FDA data

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About International device safety notices

Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.

Source: National medical device regulators (as listed), compiled by Orca1

Browse all International device safety notices