FDA-Device2017-05-31Class II
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Medtronic Inc., Cardiac Rhythm and Heart Failure
Hazard
An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.
Sold states
USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singapore
Affected count
25,025 ( 16,369 US; 8,656 OUS)
Manufactured in
8200 Coral Sea St NE, Mounds View, MN, United States
Products
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2117-2017Don't want to check this manually?
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