Product Liability and Recalls: A Scanner Darkly
March 24, 2015 | Finz & Finz, P.C.
For twenty years they’ve been on the market. For twenty years they’ve appeared on television and in movies, and even people who have never experienced an MRI firsthand still have a basic understanding of the machines. One of the most important rules, one that almost everybody knows, is how important it is that the person undergoing the scan not wear any jewelry or other metal objects.
Despite this importance, the manufacturer of many of these machines, GE, failed to include proper failsafes to insure people couldn’t disable the MRU. The MRU, or Magnet Rundown Unit, is used to shut down the MRI in the case of an emergency. One of the more common emergencies is someone wearing metal into the machine. Now, the FDA is issuing a Class 1 recall for these devices.
It can be difficult for a current operator to know if a previous employee disabled this important safety mechanism. Thankfully, the FDA recall of these machines includes directions on how to determine if the MRU is still active. But considering the device is being recalled, it seems a little strange to bother testing the MRU if use of the machine could be discontinued. It seems the FDA might not trust hospitals and laboratories to actually discontinue using these dangerous machines.
If you do need an MRI, it is important you be aware of safety concerns around these tests, particularly whether you have any metal in your body. Possible sources of metal include:
- Surgical clips
- Prosthetic devices or artificial joints
- Bullets or other foreign matter
This recall is a Class 1 recall, which the FDA associates with products that have a reasonable change to result in death. If you or someone you love was killed or harmed by a faulty MRI machine or other medical device, please contact an attorney. Again, these GE MRI machines were on the market for twenty years before someone finally stepped in and forced a recall. It is up to you to start that process for whatever dangerous device resulted in your injury.
Additional Info: Products Liability
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