The FDA issued a pair of Class II recalls on MR imaging systems. The unrelated announcements affect some devices made by GE Healthcare and Siemens.
GE notified customers in the U.S. and dozens of other countries of potential safety issues with certain Sigma, Discovery and Optima MRI systems if the software is not properly maintained. The announcement follows a Class I recall in February that affected almost 13,000 MRIs made by GE. In that more serious recall, GE cited concerns with superconducting magnets.
The FDA also took Siemens to task for component controls that it claimed did not meet Good Manufacturing Practices, potentially compromising gradient outputs. The Class 2 recall involves the Magnetom MRI system.