—#192996

Product

Azurion systems with software release R1.x

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172822
Affected lot / code info: software release R1.x

Why it was recalled

In the Azurion system, the user can add a new study to a patient by selecting the option Add Study . The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a software defect, when the study is initiated by pressing Start Procedure , the Patient Type changes inadvertently to a Patient Type different than the one selected as shown in the Table below. Patient type is one of the factors involved in the dose control process. The incorrect patient type changes the technique factors to be used by the system without notification to the user.

Root cause (FDA determination)

Software design

Action the firm took

Philips notified customers of the issue via Electronic Product Radiation Defect notification letter dated March 4, 2022. The letter identified the affected product, problem and actions to be taken. Customers were informed that they will be contacted by a Philips Field Service Engineers to schedule the software update at no cost. For questions contact your local Philips representative: 1-800-722-9377.

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: US Nationwide and Worldwide Distribution

Timeline

Recall initiated: 2021-05-26
Posted by FDA: 2022-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192996. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.