App issue triggers voluntary recall of some Siemens Healthineers CT systems

A handful of Siemens Healthineers computed tomography systems have been affected by a voluntary recall enacted by the company. 

The U.S. Food and Drug Administration’s running list of medical device recalls currently includes Siemens’ Somatom X.ceed, Naeotom Alpha, Alpha.Prime and Alpha.Pro CT scanners. Siemens self-reported an issue with software being inadvertently delivered to the systems when certain software applications— syngo.CT Brain Quantification, syngo.CT Vessel Hyperdensities, and syngo.CT Aspects—have not yet been cleared by the FDA. 

The company contacted affected customers in late December instructing them to not use the applications. In the meantime, Siemens is working to remove the applications through software updates. The company is in the process of scheduling the corrective actions now, but it can be reached at at 800-888-7436 with any questions or concerns. 

A representative for Siemens’ Medical Solutions informed Radiology Business that the company voluntarily issued the recall out of an abundance of caution, though very few customers have been affected and there have been no adverse events related to the recalls reported. Siemens also clarified that the applications have not been marketed to customers in the U.S. 

The FDA assigned Class 2 recalls for issues that have the potential to “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” 

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