CARTO 3 System

Model: FG-5400-00, Affected: All units

Catalog # FG-5400-00  Serial numbers: 11996, 11998, 11999, 12002, 12026, 12031, 12040, 12046, 12047, 12051, 12052, 12057, 12061, 12062, 12063, 12065, 12066, 12067, 12069, 12070, 12075, 12077, 12078, 12086, 12087, 12088, 12089, 12094, 12096, 12098, 12099, and 12111.

Cardiovascular Devices

2

No

Worldwide Distribution -- US, Japan, China, Ireland, Germany, Italy, Slovenia, Indonesia, Poland, Spain, United Kingdom, Switzerland, Belgium, and Canada.

CARTO 3 Systems, Product Code M-4800-01 || The intended use of the CARTO 3 System is catheter-based cardiac electrophysiological (EP) procedures.

FG-5400-00

Electrophysiology Navigation System

FG-5400-00 | 12025, 12082, 11134, 10205, 12068, 12053, 12001, 12032, 12050, 11690, 10118, 12033, 12056, 12008, 12054, 12034, 12027, 12059, R10089, 3263, 11846, 12045, 12037, 12081, 12073, 12074, 11880, 12015, 12072, 12055

MD: Cardiac mapping system