An FDA-recorded root-cause determination. The FDA lists 35 recalls with this root cause since 2025. Most recent report: May 6, 2026.
insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses…
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to t…
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or h…
Source: U.S. FDA openFDA device enforcement + RES recall records. Informational only — verify against the FDA before acting.