Nov

2016

The ORCHESTRA PLUS Programmer. Cl II

Company: Sorin Group USA, Inc.
Date of Enforcement Report 11/23/2016
Class lI:

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.
Recall Number Z-0413-2017

REASON
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.

RECALLING FIRM/MANUFACTURER
Sorin Group USA, Inc., Arvada, CO on 11/15/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
586 programmers

DISTRIBUTION
Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.

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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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The ORCHESTRA PLUS Programmer. Cl II

Amy Sellers

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