—#171662

Product

Azurion FlexArm, 722079

FDA product code: JAA — System, X-Ray, Fluoroscopic, Image-Intensified
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K181830
Affected lot / code info: Serial numbers 637, 638

Why it was recalled

During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not according to specification. This resulted in damage of the 24V power cable of the detector.

Root cause (FDA determination)

Component design/selection

Action the firm took

On March 12, 2019, the firm distributed Urgent Medical Device Correction letters to affected consignees, alerting customers that the cable set in the C-arc of the Azurion R2.0 was not according to specifications, which resulted in damage of the 24V power cable of the detector. Customers were asked to place a copy of the field safety notice together with the documentation of the system until the system is inspected and corrected (if applicable) by Philips. The firm will inspect the affected systems free of charge and correct as necessary. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.

Recalling firm

Firm: Philips North America, LLC
Address: 3000 Minuteman Rd, Andover, Massachusetts 01810-1032

Distribution

Distribution pattern: Distributed to one account in Florida, and one international account in Germany.

Timeline

Recall initiated: 2019-03-12
Terminated: 2020-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171662. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.