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Recall Observatory FDA recall evidence

Device product

Carto 3 EP Navigation System. Electro physiology system which views of the electrical activity of the heart through real-time data on 3-D, color-coded cardiac maps.

Z-0002-2016

September 10, 2015

Class II

Product summary

Firm
Biosense Webster, Inc.
Event
Event 72167
Status
Terminated
Classification
Class II
Quantity
1035 (U.S.)
Official record key
device-enforcement:Z-0002-2016

Official wording

Reason: Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

Code information: Catalog #: C3SOUND, 10439236, 10439072, 10439011, 10438577

Distribution pattern: Worldwide Distribution. US nationwide, Italy, Canada, Japan, China, Singapore, Colombia, England, Russia, Spain, France, Germany, Finland, Ireland, Australia, Sweden, Hungary, India, Brazil, Slovenia, Netherlands, Mexico, and South Africa.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.