Software glitch triggers FDA recall of nearly 2,000 GE SPECT and CT systems

The U.S. Food and Drug Administration has issued a recall of a series of CT and SPECT scanners manufactured by GE HealthCare. 

The FDA shared an update on the recall on July 8, stating that a software issue is to blame for the move. Affected products include the Infinia, Infinia Hawkeye, Infinia II, and Infinia II Hawkeye 4 systems. According to the notification, a software glitch can cause the scanners to inadvertently move during scans.

“Unintended radial detector motion may occur during patient setup or during patient scan if [the] system does not have a correct version of gantry software installed,” the notice reads. “Unintended detector motion may result in life-threatening injury.” 

The recall is considered Class 2, which is defined as “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.” 

On June 20, GE sent its customers Urgent Medical Device Correction letters informing them of the software issue. The letter instructs users to check the software version that is installed on the scanner—V.25BK for Infinia Running on Windows2000 (Win2K), C.15BK or C.1523 for Infinia on Windows XP and V.60BK on VG (all operating systems). For those who do not have the correct software installed, GE recommends temporarily ceasing use of the system and contacting GE HealthCare Service or a local service representative. 

Device corrections include a hardware update and possibly a software change as well. These corrections will be at no cost to the customer but will require an on-site visit from a representative. GEHC requests that affected customers contact GE HealthCare Service at 800-437-1171 to arrange a correction. 

There are 1,800 affected units currently in operation globally. 

Learn more about the specifics of the recall here.