FDA-Device2013-04-03Class II
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Biosense Webster, Inc.
Hazard
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Sold states
Worldwide Distribution - USA (Nationwide) including the states of: DE, NL, CH, FR, GB, DK.
Affected count
54 units
Manufactured in
15715 Arrow Hwy, Irwindale, CA, United States
Products
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the LASSO NAV Eco Catheter and CARTO 3 System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1023-2013Don't want to check this manually?
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