The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring implant patients.
FDA Recall Z-0413-2017 · Posted None
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Recalling FirmSorin Group USA, Inc.
Recall StatusTerminated
Product CodeKRG
Date Initiated2016-09-29
Date Terminated2020-05-15
Product Quantity586 programmers
Reason for Recall
Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS
Programmer because the residual longevity estimate may be less accurate.
Firm Action
The firm, LivaNova, sent an "Urgent Field Safety Notice" dated 9/29/2016 to its customers. The notice described the product, problem, actions to be taken. The notice states that a Sorin representative will contact customers to upgrade the software in the facility's programmer.
If customers have any questions, they are urged to call their LivaNova representative or contact LivaNova Technical Services at 877.663.7674.
Root Cause
Software Design Change
Distribution Pattern
Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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