Azurion
FDA device recall Z-2403-2023 · posted 2023-09-07 · Open, Classified
Recall details
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Reason for recall
- A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
- Action taken
- Philips will send a customer notification to the existing users of the affected systems to alert them of the issue and provide actions that should be taken by the customer/user in order to prevent risks to patients. Philips will contact customers to schedule a visit to inspect the foot switch and provide an addendum to the Instructions for Use (IFU) of the system detailing the appropriate cleaning and maintenance instructions. (Philips reference 2023-IGT-BST-011).
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Open, Classified
- Product code
- OWB
- Quantity affected
- 5432 systems in total
- Distribution
- US Nationwide Distribution
- Date initiated
- 2023-07-19
- Date posted
- 2023-09-07
- Location
- Eindhoven, Netherlands
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Azurion R2.1 (K200917) | Philips Medical Systems Nederland B.V. | 2020-05-01 |
| Azurion R2.0 (K181830) | Philips Medical Systems Nederland B.V. | 2018-08-02 |
| Azurion series R1.2 (K172822) | Philips Medical Systems Nederland B.V. | 2017-11-22 |