Philips Healthcare (NYSE:PHG) recalled its Xcelera Connect cardiovascular patient data reporting system after the company discovered a flaw that could result in patient misdiagnosis and improper treatment decisions.
The problem arose from a software defect in the Xcelera system, which transmits data from an ultrasound cardiologic lab to the patient’s electronic medical record. When healthcare providers used the "enter" key to create a line break in the data, everything below that line break was sometimes stripped from the final record.
The system does not indicate that there is data was missing, so a physician using the record to make a diagnosis or recommend treatment may be doing so without knowing the full scope of the problem, the Wall Street Journal reported.
There are more than 220 Xcelera Connect users, but the issue only affected about 20 based on how their systems were structured, spokesperson Steve Kelly told MassDevice.com today.
The FDA gave the recall Class II status, designating it 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."
The issue was initially noticed by 1 customer who reported it to the company, Kelly told us. Philips isolated the problem, created a patch and quickly notified every user as a precaution. The company is in the process of updating each system with the software patch.
Philips took fast action on the defect, but that was little comfort to some.
"How the hell does this [flaw] get out?" managing director Mike Davis of healthcare research firm The Advisory Board Company told the Journal. "It shows there wasn’t good quality assurance processes in place."
"We extensively test all of our products," Kelly told us. "We’re also diligent in reporting to the FDA. Before they posted this notice we had already rectified the situation."
"In our opinion, this worked the way that it was supposed to," he added.
No patient injuries have been reported in relation to the software defect.
Join us Oct. 8-10 for the 7th annual DeviceTalks Boston, back in the city where it all began.
DeviceTalks offers three days of world-class education, networking, and a technology exhibition featuring the leading companies in the industry.
Early Registration is now open.