FDA-Device2016-11-23Class II
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.
Sorin Group USA, Inc.
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.
Sold states
Programmers were distributed nationwide, to VA/govt/military, Canadian, and other foreign consignees.
Affected count
586 programmers
Manufactured in
14401 W 65th Way, N/A, Arvada, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0413-2017Don't want to check this manually?
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