In recent times we’d stopped covering recalls, mainly because the various regulatory agencies and companies around the world do a pretty good job of communicating with necessarily interested parties. This FDA one’s a whopper though, applying as it does to almost 13000 MRI Systems around the world.
The FDA Class I recall can be found here and applies to GE Healthcare’s (GEHC), Nuclear Magnetic Resonance Imaging systems with superconducting magnets, which incorporates a bunch of products and a gigantic list of item numbers, all findable on the correction notice itself.
The reason for the recall is that at certain sites, the Magnetic Rundown Unit (MRU) may not be connected to the magnet, seemingly as a result of in-field modification. GEHC says this is a condition that could delay removal of a ferrous object from the magnet, with potentially life-threatening consequences, confirming that the MRU must be connected to the magnet at all times.
GE Healthcare has sent an “Urgent Medical Device Correction” letter to affected consignees, describing the Safety Issue, Safety Instructions, Affected Product Details, Product Correction & Contact Information. Customers were instructed to confirm that MRU is connected to the magnet by performing the a four step test on the MRU. In the event that the MRU test does not pass these tests users are strongly recommended by GEHC to stop using the system, and immediately call their GEHC representative.
According to the recall notice, there are 12,968 (5,708 US, 7,260 OUS) units out there at risk.