International safety notice
Escáneres Whole-Body MR de GE: SIGNA Premier, SIGNA Pioneer, SIGNA Architect, SIGNA Creator, SIGNA Explorer, SIGNA MR355, SIGNA MR360, SIGNA MR380, SIGNA PET/MR, SIGNA Voyager, SIGNA Artist,1.5T, Signa HDxt (HD28), Optima MR450w 1.5T.
Spain / AEMPS · ESP · Jul 20, 2021
Key facts
| Title | Escáneres Whole-Body MR de GE: SIGNA Premier, SIGNA Pioneer, SIGNA Architect, SIGNA Creator, SIGNA Explorer, SIGNA MR355, SIGNA MR360, SIGNA MR380, SIGNA PET/MR, SIGNA Voyager, SIGNA Artist,1.5T, Signa HDxt (HD28), Optima MR450w 1.5T. |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Escáneres Whole-Body MR de GE: SIGNA Premier, SIGNA Pioneer, SIGNA Architect, SIGNA Creator, SIGNA Explorer, SIGNA MR355, SIGNA MR360, SIGNA MR380, SIGNA PET/MR, SIGNA Voyager, SIGNA Artist,1.5T, Signa HDxt (HD28), Optima MR450w 1.5T. |
| Manufacturer | GE Medical Systems, LLC, EEUU. GE Healthcare Japan Corporation, Japón. GE Healthcare (Tianjin) Company Limited, China. |
| Models | 3.0TDISCOVERY, 35-37, 60978-2B, 00840682113786, 00840682147095, SV25.2, 1.5TSIGNA, MR360, PX26.4, PX25.2, SV29.1, 00195278023643 and 64 more |
| Event type | Safety Notice |
| Date | Jul 20, 2021 |
At a glance
- No Recall
- Yes 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