A901 Communication Manager Software Update Not Available for Intellis System
The A901 Communication Manager application did not receive a timely update to match the A710 Clinician Programmer software release for Intellis Neurostimulation Systems, creating a version mismatch.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: This is an FDA Class II recall involving a software version synchronization issue with no reported illness, injury, or death. The hazard is a version mismatch between companion applications; no clinical harm has been documented in the source.
Plain-English summary
Medtronic Neuromodulation has issued a Class II recall of the A901 Communication Manager Application, software used with the A710 Clinician Programmer application to support the Intellis Neurostimulation System. Two clinician tablets with serial numbers NPL3011706 and NPL3016791, distributed to Israel and Serbia, are affected.
When an update to the A710 Clinician Programmer software was released, the corresponding version of the A901 Communication Manager application was not made available for download. This version mismatch between the two interdependent applications prevents synchronized operation of the software tools that manage the neurostimulation system.
The recalled product
- Product
- A901 Communication Manager Application, used in conjunction with the A710 Clinician Programmer application..
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Serial numbers NPL3011706 and NPL3016791
- UDI-DI 643169738058.
Distribution
Distribution scope not specified by the agency.
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