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.
___________________________________
