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U.S. Department of Health and Human Services

Class 2 Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer

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  Class 2 Device Recall ORCHESTRA/ORCHESTRA PLUS Programmer see related information
Date Initiated by Firm November 20, 2013
Date Posted January 22, 2014
Recall Status1 Terminated 3 on September 08, 2014
Recall Number Z-0805-2014
Recall Event ID 67013
PMA Number P950029S041 P980049S050 P060027S011 P980049S006 
Product Classification Medical Computers and software - Product Code LNX
Product ORCHESTRA/ORCHESTRA PLUS Programmer
Code Information ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1
Recalling Firm/
Manufacturer		 Sorin Group Italia S.r.l.
Via Crescentino
Saluggia, VC Italy
For Additional Information Contact Steve Smith
303-467-6222
Manufacturer Reason
for Recall		 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 Determined
Cause 2		 Software design
Action On Nov 20 and Nov 25, 2013, the Dear Doctor Letter was sent by certified mail to 1,310 physicians who are following 13,003 patients implanted with a REPLU or ESPRIT pacemakers in the US. Sorin provided the following recommendations to the physicians:  You should consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k¿, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit.  When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre.  As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k¿. This recommendation should also be followed subsequent to the installation of the new programmer software version.
Quantity in Commerce 1,718
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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