International safety notice
Urgent Field Safety Notice for Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation.35T, Signa HFO, Signa Ovation with by GE Medical Systems, LLC
Germany / BfArM · DEU · Dec 14, 2018
Key facts
| Title | Urgent Field Safety Notice for Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with by GE Medical Systems, LLC |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Signa OpenSpeed, Signa Infinity with Excite Technology, Signa Excite 3T, Signa Infinity & Signa Infinity Twinspeed, Signa Profile, Signa Ovation .35T, Signa HFO, Signa Ovation with |
| Manufacturer | GE Medical Systems, LLC |
| Models | OVATION5.293A_M4_0737.A, OPENMR4.292A_M4_0844.A.PB, OPENMR4.292A_M4_0844.A.PA, 91.29I_M4A_0723.D, E2.0_M4_0502.B, HD23.0_V03, OPENMR5.293A_M4_0838.A, PROFILEHD.0_M4_0736.A.PE, OPENMR4.292A_M4_0844.A, G3.0_M4B_0513.A, SV20.1_IB3_1213.A.PC, SV20.1_IB3_1213.A.PB and 24 more |
| Date | Dec 14, 2018 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
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