International safety notice
Sistemas de Resonancia Magnética (RM):Signa OpenSpeed,Infinity con tecnología Excite,Excite 3T,Infinity y Infinity Twinspeed,Profile,Ovation.35T,HFO,Ovation con Excite,0.7T OpenSpeed,Ovation HD,HDe,1.5T HDxt,Creator,Explorer,Brivo MR355,Optima MR360
Spain / AEMPS · ESP · Dec 20, 2018
Key facts
| Title | Sistemas de Resonancia Magnética (RM):Signa OpenSpeed,Infinity con tecnología Excite,Excite 3T,Infinity y Infinity Twinspeed,Profile,Ovation .35T,HFO,Ovation con Excite,0.7T OpenSpeed,Ovation HD,HDe,1.5T HDxt,Creator,Explorer,Brivo MR355,Optima MR360 |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Sistemas de Resonancia Magnética (RM):Signa OpenSpeed,Infinity con tecnología Excite,Excite 3T,Infinity y Infinity Twinspeed,Profile,Ovation .35T,HFO,Ovation con Excite,0.7T OpenSpeed,Ovation HD,HDe,1.5T HDxt,Creator,Explorer,Brivo MR355,Optima MR360 |
| Manufacturer | GE Medical Systems LLC., Estados Unidos |
| Models | 35TSIGNA, E2.0_M4_0502.B, OVATIONHD.0_M4_0909.A.PD, G3.0_M4B_0513.A, OPENMR5.293A_M4_0838.A.PB, HD23.0_V01_1210.A1, 28022, HFO3.29I_M4_0320.A, PROFILEHD.0_M4_0736.A.PE, SV20.1_IB3_1213.A.PA, OPENMR4.292A_M4_0844.A, OPENMR4.292A_M4_0844.A.PA and 33 more |
| Event type | Safety Notice |
| Date | Dec 20, 2018 |
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