Recall Z-0886-2022 ยท OWB Interventional Fluoroscopic X-Ray System
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion systems with software release R1.x
| Date | May 3, 2022 (initiated May 26, 2021) |
| Status | Open, Classified |
| Reason | 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 | Software design |
| Action | 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. |
| Quantity | 722 systems |
| Distribution | US Nationwide and Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172822 | Azurion series R1.2 Philips Medical Systems Nederland B.V., Nov 22, 2017 |