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CARTO 3 EP SYSTEM - CARTOSOUND MODULE (2015-09-25)
- Starting date:
- September 25, 2015
- Posting date:
- October 22, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-55514
Affected Products
CARTO 3 EP SYSTEM - CARTOSOUND MODULE
Reason
Biosense Webster is initiating a field safety notice for the CARTOSound Module of the CARTO 3 EP Navigation System, when used with the SOUNDSTAR eco 8F Diagnostic Ultrasound Catheter [see second recall record] following one complaint of image disappearance from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting. This occurred while the patient was experiencing pericardial effusion.
Affected products
CARTO 3 EP SYSTEM - CARTOSOUND MODULE
Lot or serial number
11933
R10035
Model or catalog number
FG540000
FG560000
Companies
- Manufacturer
-
Biosense Webster (Israel) Ltd.
4 Hatnufah Street
Yokneam
2066717
ISRAEL