Z-0886-2022 Class II Ongoing
FDA device recall Z-0886-2022 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on May 26, 2021 and is designated Class II. 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 s… The recall status is ongoing. Affected quantity: 722 systems.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2022
- Initiation Date
- May 26, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 722 systems
Product Description
Azurion systems with software release R1.x
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.
Distribution Pattern
US Nationwide and Worldwide Distribution
Code Information
software release R1.x