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.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential inaccuracy in longevity estimates, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Sorin Group USA, Inc. has announced a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer. The recall involves 586 units of the portable device, which is equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The device also provides measurement, ECG display, and report printing functions essential for monitoring implant patients.
The reason for the recall is that the residual longevity estimate provided by the device may be less accurate. This inaccuracy could impact the monitoring of patients with implantable cardiac devices. The affected programmers were distributed nationwide to VA/government/military facilities, Canadian consignees, and other foreign consignees.
Consumers and healthcare providers should check the serial numbers of their devices against the list provided in the official recall notice to determine if their unit is affected. If a device is affected, users should contact Sorin Group USA for further instructions on the field action.
The recalled product
- 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
- Manufacturer
- Sorin Group USA, Inc.
- Hazard
- Affected units
- 586
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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