The FDA has issued separate Class II recalls for MRI systems from GE Healthcare and Siemens.
The GE recall is related to software updates for certain Signa, Discovery and Optima systems. “GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites,” wrote the FDA.
The GE recall affects more than 9,000 installed systems worldwide, including nearly 3,000 in the U.S. The company sent a letter to affected customers earlier this month to describe the issue and how to correct it. Those with additional questions were directed to contact a local service representative.
The Siemens recall notice was regarding Magnetom MRI systems in which gradient output supervision was permanently disabled. As with the GE recall, Siemens customers received a letter informing them of the issue. A total of 132 installed systems are affected, according to the FDA.