Stop Using the Cardiogen-82; Scanner Recalled

Shelley Wood

July 26, 2011

July 26, 2011 (Rockville, Maryland)— The FDA is now telling physicians to stop using the CardioGen-82 cardiac positron-emission tomography (PET) scanner after issuing an earlier alert about a risk of increased radiation exposure due to an isotope "breakthrough" problem [1]. The device manufacturer, Bracco Diagnostics, has voluntarily recalled the device.

CardioGen-82 is a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injection used for nuclear medicine scans, the FDA alert notes.

As previously reported by heartwire , the FDA issued a July 15, 2011 alert noting that it had received two reports of patients who received more than the expected radiation dose while undergoing cardiac PET scans with Rb-82 chloride injection. According to that communication, the excess radiation exposure occurred as a result of a "strontium breakthrough" problem with the CardioGen-82, and the FDA was investigating the cause.

In the alert issued today, the FDA notes that after further investigation, the agency "has determined that the current CardioGen-82 manufacturing procedures are not sufficient to ensure reliable performance of the generator used to produce the Rb-82 chloride injection. Reliable generator performance is essential to help prevent strontium breakthrough from CardioGen-82 and to prevent patients from being exposed to excess radiation." 

Today's alert does not say that additional cases have been identified, although it does say that the FDA is investigating whether the tests used at sites that used the CardioGen-82 are "sufficient" to have accurately detected strontium breakthrough from the scanner.

The agency is advising physicians who use this scanner to use alternative imaging tests for their nuclear medicine cardiac scans and that patients who have questions or concerns should contact their physicians.


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