FDA-Device2019-11-06Class I
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Thoratec Switzerland GMBH
Hazard
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Sold states
Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, Romania, Singapore, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, and United Kingdom.
Affected count
664 units (381 U.S. and 283 OUS)
Manufactured in
Technoparkstrasse 1, Zurich, Switzerland
Products
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0221-2020Don't want to check this manually?
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