Azurion systems with software release R1.x
FDA device recall Z-0886-2022 · posted 2022-05-03 · Open, Classified
Recall details
- Recalling firm
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 722 systems
- Distribution
- US Nationwide and Worldwide Distribution
- Date initiated
- 2021-05-26
- Date posted
- 2022-05-03
- Location
- Best, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion series R1.2 (K172822) | Philips Medical Systems Nederland B.V. | 2017-11-22 |