International safety notice
Urgent Field Safety Notice for BrightSpeed (Elite/Edge/Excel/Select), Brivo (CT315/CT325 +CT385), HiSpeed Dual, ProSpeed FII, HiSpeed Series, CTe, ProSpeed AI/FI, CTe Dual, ProSpeed AII/FII, Optima CT520 Series (+ with DoD), Optima Advance, Optima CT540, Optima by GE Hangwei Medical Systems CO., LTD
Germany / BfArM · DEU · Jul 27, 2022
Key facts
| Title | Urgent Field Safety Notice for BrightSpeed (Elite/Edge/Excel/Select), Brivo (CT315/CT325 +CT385), HiSpeed Dual, ProSpeed FII, HiSpeed Series, CTe, ProSpeed AI/FI, CTe Dual, ProSpeed AII/FII, Optima CT520 Series (+ with DoD), Optima Advance, Optima CT540, Optima by GE Hangwei Medical Systems CO., LTD |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | BrightSpeed (Elite/Edge/Excel/Select), Brivo (CT315/CT325 +CT385), HiSpeed Dual, ProSpeed FII, HiSpeed Series, CTe, ProSpeed AI/FI, CTe Dual, ProSpeed AII/FII, Optima CT520 Series (+ with DoD), Optima Advance, Optima CT540, Optima |
| Manufacturer | GE Hangwei Medical Systems CO., LTD |
| Models | 2188543, CT750, 00840682103534, 5101900-20, 00840682146159, 00840682125703, 2113694-2, 00840682137553, 00840682125574, 5440658-2EN, 5121647, 00840682102674 and 158 more |
| Date | Jul 27, 2022 |
| 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