Software glitch prompts recall of PET/CT systems

A group of positron emission/computed tomography systems are the subject of a new Class 2 recall by the U.S. Food and Drug Administration.  

The PET/CT systems, which are manufactured by Shanghai United Imaging Healthcare Co., made their way onto the list of medical device recalls due to an issue with their software design. According to a notice on the FDA’s website, the glitch can trigger the need for unnecessary repeat imaging. 

“[The] positron emission tomography and computed tomography X-ray systems have a software problem when split or local function is enabled, and multiple RIS exams are merged into a single study, that prevents patient images from being visible on the patient administration interface, which may result in the need for rescans,” the notice reads. 

The company became aware of the issue in August. At that time, it sent out correction notices to affected customers that provided information on how to work around the glitch. 

The following instructions were shared for operators attempting to use the split function: 

1) Temporarily disable the "study split" function. Navigate to the system configuration interface and uncheck the "auto study split" option.  

2) If the "study split" function is clinically necessary, open the system configuration interface and select "split on PACS" instead of "split on local.” 

3) When "auto study split" is checked, ensure that PACS (picture archiving and communication system) is configured on site and auto-archive is enabled.  

4) If images are found to be missing on the PA interface, immediately verify whether the corresponding image data exists in the PACS; If images exist in PACS, they can be retrieved from PACS for review., but if they do not exist in the PACS, contact the firm's service engineer for assistance. 

The systems are in distribution throughout the U.S. Affected customers are encouraged to call the customer contact center at 855-221-1552 or 832-699-2799. 

Learn more here.