A single Model A710 Intellis Clinician Programmer Application (version 2.0.97) has been recalled due to a software issue that prevents it from communicating with a patient's Implantable Neurostimulator (INS). This communication failure means a clinician cannot adjust the patient's stimulation settings as needed. Only one tablet unit is affected by this recall, which was distributed in Germany. Because this device is used for pain management therapy, the failure to adjust settings may result in the patient receiving therapy that is either too strong or too weak, leading to inadequate pain relief.
The software defect prevents the clinician programmer from establishing a session with the implanted neurostimulator, which stops clinicians from making necessary therapy adjustments. This can lead to the patient receiving improper stimulation levels, potentially resulting in increased pain or physical discomfort.
Manufacturer Notification
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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