Recall Z-0413-2017— Sorin Group USA, Inc.
Class II · Terminated
Class II FDA medical device recall by Sorin Group USA, Inc., initiated 2016-09-29, terminated 2020-05-15. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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
- Sorin Group USA, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-09-29
- Terminated
- 2020-05-15
- Firm location
- Arvada, CO, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.