FDA-Device2014-01-29Class II
ORCHESTRA/ORCHESTRA PLUS Programmer
Sorin Group Italia S.r.l.
Hazard
Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.
Sold states
Nationwide.
Affected count
1,718
Manufactured in
Via Crescentino, Saluggia, VC, Italy
Products
ORCHESTRA/ORCHESTRA PLUS Programmer
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0805-2014Don't want to check this manually?
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