Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
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Recall Number
Z-0936-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2025-10-25
Reported
2025-12-24
Distribution
Domestic: LA, MA, MN;
Code Info
Model Number: M204441; UDI-DI: 00840861102433; All serial numbers produced with a software version prior to 4.82.4;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.