Software glitch prompts FDA recall of popular PET systems
A group of PET scanners manufactured by GE HealthCare are the subject of a new recall from the U.S. Food and Drug Administration (FDA).
On January 16, the FDA updated its list of medical device recalls to include certain Omni Legend systems from GE. The recall was issued due to the potential for the systems to produce artifacts during PET exams, which could skew readers’ ability to assess images accurately.
“There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation),” the FDA’s notice reads.
According to GE, the issue is related to the systems’ software design. In late December, GE sent Urgent Medical Device Correction letters to all of its affected customers. Those letters informed users of the glitch, detailed potential safety risks and provided additional information about how to work around the issue until a proper correction is implemented.
The FDA notification indicates that 364 units are affected by the recall. These units are in operation globally, including in the United States. The recall has been categorized as Class II, which the FDA designates for issues that have the potential to “cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
Those with questions or concerns regarding the issue can contact GE HealthCare Service at 1-800-437-1171 or reach out to their local Service Representative.
A spokesperson for GE HealthCare reached out to Radiology Business to share that the company is actively working on resolving the issue.
“Patient safety is our top priority. Hospitals can continue using their device by following instructions provided in our recall letter," an email to RB noted. "We are in the process of implementing a software correction for all impacted systems. There have been no reports of patient injury as a result of this potential issue."
More information regarding the specific systems impacted by the recall can be found here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.