Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Philips Medical Systems Nederland B.V. has issued a medical device safety alert concerning its Azurion Systems R1.2, R2.0, R2.1 and R2.2 [HKMD No.:200480 and 230373].
| System product name | Model number |
|---|---|
| Azurion 3M12 | 722063, 722221 |
| Azurion 3M15 | 722064, 722222 |
| Azurion 5M12 | 722227 |
| Azurion 5M20 | 722228 |
| Azurion 7B12/12 | 722067, 722225 |
| Azurion 7B20/15 | 722068, 722226 |
| Azurion 7M12 | 722078, 722223 |
| Azurion 7M20 | 722079, 722224 |
The manufacturer identified the issue of technical data being inconsistent between the Instructions For Use and Technical Documentation Specifications for Philips Azurion R1.2, R2.0, R2.1 and R2.2. The manufacturer is providing the updated information regarding the Instructions for Use for Azurion Systems R1.2, R2.0, R2.1, R2.2 with Important Product Notice (IPN 2023-IGT-BST-003) and the IFU addendum “Philips Azurion –Technical Data”.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 26 Jul 2024