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Sorin Group USA, Inc. recalls The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sori
Recalled November 23, 2016 · FDA recall Z-0413-2017 · Sorin Group USA
Hazard
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. · FDA Class II
Units
586 programmers
Sold at
Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
Description
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.
Product
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.
Manufacturer(s)
Sorin Group USA, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →