Recall Z-2776-2016— Biosense Webster, Inc.
Class II · Terminated
Class II FDA medical device recall by Biosense Webster, Inc., initiated 2016-08-15, terminated 2017-01-20. It names 3 FDA 510(k) clearances: K133916, K132782, K112007. Product: CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.. Reason: Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU)..
- Recalling firm
- Biosense Webster, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-15
- Terminated
- 2017-01-20
- Firm location
- Irwindale, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K133916 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2
- K132782 — CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2
- K112007 — CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
CARTO 3 EP Navigation System and Accessories, Product Codes: FG540000 and FG540000C, Software Versions: v 3.2 , v 4.3 and v 2.3. The CARTO 3 EP Navigation System is intended to be used in catheter-based cardiac electrophysiological (EP) procedures. The CARTO 3 System provides information about the electrical activity of the heart and catheter location during the procedure.
Reason for recall
Biosense Webster, Inc. is initiating a voluntary correction to re-install identified CARTO 3 Systems that were moved and installed in China without testing and approval by Biosense Webster Technical Services, as described in the Instructions for Use (IFU).
Data sourced from openFDA. This site is unofficial and independent of the FDA.