The Food and Drug Administration has issued two separate Class 2 recalls involving Siemens and GE MRI systems.
The GE recall affects 9,369 GE Signa, Discovery and Optima MRI systems (6,432 outside the United States). GE sent an “Urgent Medical Device Correction” letter dated March 9 to affected customers warning of potential safety issues due to the software versions being improperly maintained at some sites.
This recall follows a class I recall in February affecting about 13,000 GE MRIs.
The Siemens recall involves 132 MAGNETOM systems. According to the FDA, the reason for the recall was that the “gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur." On March 6 a Customer Service Advisory Notice was sent to end users notifying them of the issue and the steps that were being taken to mitigate the problem.