FDA-Device2018-08-22Class II
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Sorin CRM SAS
Hazard
Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.
Sold states
US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS
Affected count
16
Manufactured in
Cvk, 4, avenue Reaumur, Clamart Cedex, France
Products
Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2824-2018Don't want to check this manually?
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