The U.S. Food and Drug Administration (FDA) classified an action by GE Healthcare regarding its Nuclear Medicine Systems as a class I recall because a patient died during an imaging scan.
What Is a Nuclear Medicine System?
Nuclear medicine systems are imaging devices that detect radioactive isotopes injected into patients’ bodies to help doctors to investigate symptoms caused by injuries and diseases.
GE Healthcare Nuclear Medicine Systems Might Be Dangerous
In the spring of 2013, a patient at a Veterans Affairs medical center died due to injuries sustained while undergoing a scan by an Infinia Hawkeye 4 Nuclear Medicine System. On June 3, 2013, GE Healthcare promptly ordered a recall of all its nuclear medicine system devices to run diagnostic tests to ensure that they did not fail in the same way.
On July 29, 2013, the FDA notified the public that GE Healthcare’s June 3rd action was a class I recall, the agency’s most serious kind of alert, because “there [was] a reasonable probability that the use of or exposure to a violative product [would] cause serious adverse health consequences or death.”
The FDA’s recall announcement lists the following devices that are affected by the recall:
- Infinia 3/8
- Infinia-II 3/8
- Infinia VC
- Infinia II VC
- Infinia 3/8 Hawkeye
- Infinia VC Hawkeye
- Infinia II 3/8 Hawkeye
- Infinia II VC Hawkeye
- Infinia II 3/8 HE4
- Infinia II 5/8 HE4
- Infinia II VC HE4
- Varicam, Millennium VG 3/8
- Millennium VG 5/8
- Millennium VG 3/8 Hawkeye
- Millennium VG 5/8 Hawkeye
- Discovery VH
- Helix nuclear medicine systems
- Brivo NM615
- Discovery NM630
- Optima NM/CT640
- Discovery NM/CT670
RLG’s Lawyers Will Make Things Easier
The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a nuclear medicine system lawsuit on your behalf if necessary.
If you believe a nuclear medicine system injured you or a loved one, contact RLG today.