International safety notice
Sistema CARTO® 3, Módulo CARTO VISITAG®:CARTO PRIME™,número catálogo KT5400222;CARTO PRIME™(JPN),número catálogo KT5400222G;CARTO PRIME™ (OBL),número catálogo KT5400222U;CARTO® 3 V7,número catálogo KT5400221;CARTO® 3 V7 (OBL),número catálogo KT5400221U
Spain / AEMPS · ESP · Jul 2, 2020
Key facts
| Title | Sistema CARTO® 3, Módulo CARTO VISITAG®:CARTO PRIME™,número catálogo KT5400222;CARTO PRIME™(JPN),número catálogo KT5400222G;CARTO PRIME™ (OBL),número catálogo KT5400222U;CARTO® 3 V7,número catálogo KT5400221;CARTO® 3 V7 (OBL),número catálogo KT5400221U |
|---|---|
| Regulator | Spain / AEMPS |
| Country | ESP |
| Brand | Sistema CARTO® 3, Módulo CARTO VISITAG®:CARTO PRIME™,número catálogo KT5400222;CARTO PRIME™(JPN),número catálogo KT5400222G;CARTO PRIME™ (OBL),número catálogo KT5400222U;CARTO® 3 V7,número catálogo KT5400221;CARTO® 3 V7 (OBL),número catálogo KT5400221U |
| Manufacturer | Biosense Webster Ltd., Israel |
| Models | 2020-366, 28022, 92618, V7.1.80, SOFTWAREV7.1.80, KT5400222G, KT5400222CARTO, KT5400221CARTO®, 28042, 91.822.52.89, KT5400221U, KT5400221 and 5 more |
| Event type | Safety Notice |
| Date | Jul 2, 2020 |
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