Medtronic Neuromodulation Clinician Programmer Application Software Anomaly Recall
Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.
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: FDA Class II precautionary recall for a software anomaly with no reported illnesses or injuries. The source does not specify what the anomaly does, and the 'may occur' language indicates theoretical rather than confirmed risk.
Plain-English summary
The Clinician Programmer Application (CPA) model A610 is a software application by Medtronic Neuromodulation used in clinical settings. The FDA issued a Class II recall for this software due to a potential software anomaly.
The recall affects CPA model A610 software versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081. These versions have been distributed worldwide, including the United States, Australia, New Zealand, Canada, Europe, India, Japan, Korea, the Middle East, Latin America, Africa, Southeast Asia, and China. Approximately 3,302 units are affected.
No illnesses or injuries have been reported in association with this software anomaly. The FDA classified this as a Class II recall. Medtronic Neuromodulation is the recalling firm. The FDA recall notice number is Z-0201-2022.
The recalled product
- Product
- Clinician Programmer Application (CPA) model A610 Clinician Software Application
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- software-anomaly
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 (4)
- Clinician Programmer Application (CPA) model A610 version 3.0.1048
- 3.0.1057
- 3.0.1062
- and 3.0.1081
Distribution
Distributed nationwide across the United States.
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