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Sorin Group Italia S.r.l. recalls ORCHESTRA/ORCHESTRA PLUS Programmer
Recalled January 29, 2014 · FDA recall Z-0805-2014 · 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. · FDA Class II
Units
1,718
Sold at
Nationwide.
Description
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.
Product
ORCHESTRA/ORCHESTRA PLUS Programmer
Manufacturer(s)
Sorin Group Italia S.r.l.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →