The U.S. Food and Drug Administration has issued a Class 2 recall for Philips Azurion interventional fluoroscopy systems after the company identified a wired foot switch issue.
X-ray imaging may not be initiated or may occur intermittently when the wired foot switch is used, according to the FDA recall record. The agency listed the determined cause as device design.
Philips sent urgent medical device correction letters to affected customers on March 3. Customers were instructed to circulate the letter to all users, perform a daily check before the first procedure of the day, report foot switch activation issues to a local Philips representative, and keep the letter with system documentation until correction is completed.
A related field safety notice dated February 26 described the issue as a potential loss of imaging functionality resulting from no or intermittent X-ray radiation initiation through the wired foot switch.
The correction applies to Philips Azurion systems manufactured by Philips Medical Systems Nederland in Best, Netherlands. The FDA recall entry lists the recall status as open.
Sources
- Class 2 Device Recall Azurion Series. Regulatory filing
- Urgent Field Safety Notice: Philips Azurion and Allura Systems. Regulatory filing
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