Sorin Group USA, Inc. recalls The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin i…

Recall date

September 29, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0413-2017

FDA classification

Class II

Brand / firm

Sorin Group USA, Inc.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.