FDA Watch List: CardioGen-82 PET Scanner
A scanner used to give patients cardiac PET scans has found its way onto the Food and Drug Administration’s “Adverse Event Reporting System” (AERS) list because of potentially risky levels of radiation exposure it may cause patients.
The CardioGen-82 cardiac PET scanner, which is manufactured by Bracco Diagnostics, was placed on the FDA’s AERS list because the device may potentially cause unintended radiation exposure to strontium isotopes following a myocaridal imaging procedure.
Last July, the scanner was recalled by the FDA after it received two reports that patients received higher-than-expected doses of radiation while undergoing PET scans that used Rb-82 chloride injections produced by the device.
The AERS watch list documents potential safety risks that were gathered during the final quarter of 2011.
It is important to note that the FDA has not yet determined whether or not products listed on the AERS watch list pose a health risk. Instead, it means that additional studies will be undertaken to see if there is a link between the product and a potential health risk. Possible regulatory responses, such as a change in the product’s labeling or a recall, could be pursued by the FDA if such a link is found.
If you or a loved one has been harmed by a dangerous medical device, there are legal actions at your disposal. Call Sokolove Law to learn more about pursuing a product liability lawsuit today at (877) 490-6520.