The Recall Desk

FDA (Devices) recall action 75456

Sorin Group USA, Inc. recalled 2 products on 2016-11-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2016-11-23
Critical
0
Units
1,433

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2016-11-23

    Sorin Orchestra Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is voluntarily recalling 847 Orchestra and Orchestra Plus programmers because residual longevity estimates may be inaccurate.

    Product
    The ORCHESTRA 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 im
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2016-11-23

    Sorin Orchestra Plus Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is recalling 586 Orchestra Plus programmers because their residual longevity estimates may be inaccurate, potentially affecting patient monitoring.

    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 monitori
    Category
    Distribution
    1 state