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.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and is a voluntary field action addressing a potential inaccuracy in longevity estimates without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Sorin Group USA, Inc. has announced a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer. The recall involves 847 units of these portable devices, which are equipped with microprocessors used to program and interrogate Sorin implantable pacemakers and defibrillators.
The reason for the field action is that the residual longevity estimate provided by the devices may be less accurate. These programmers also provide measurement, ECG display, and report printing functions that are essential for monitoring implant patients.
The affected programmers were distributed nationwide to VA/government/military facilities, Canadian consignees, and other foreign consignees. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- 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
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 847
Distribution
Part of a larger recall action
This product is one of 2 recalled by Sorin Group USA, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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