Reported Nov 23, 2016 · Terminated
The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin…
Sorin Group USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sorin Group USA, Inc. · 14401 W 65th Way · Arvada, CO · 80004-3503
Is this the product you have?
- 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.
- Lot codes and dates
- Serial Numbers
1,758 of 1,758 codes
NB1006418KNB1107409KNB1203456KNB1107407KNB1105419KNB0908405KNB1202447KNA0804365KNB1201447KNA0807425KNB0909407KNB1112470KNB0909402KNB1112474KNB1112444KNB1201403KNB1201402KNB1102423KNB1112471KNA0804393KNB1203431KNA0804389KNB1004403KNB1202418KNB1108403KNB1007410KNB1105438KNA0804367KNB1102406KNA0804384KNB1202458KNA0804321KNB1006415KNB1201455KNB1102402KNB1107417KNB1109421KNB1202454KNC1503413KNA0804353KNB1112482KNB1108404KNB1105436KNB0907430KNB1112485KNA0804343KNB1109418KNB1104409KNB1112414KNB0908415KNB1112407KNB1108425KNB1006402KNB1203428KNA0804426KNA0804390KNB0911402KNB0907419KNB0909417KNB1203415K
- Serial Numbers
- Amount recalled
- 586 programmers
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- VA
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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