Recall Z-2892-2026
Philips Medical Systems Nederland B.V. · initiated June 17, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 722228, 722281. 5. Azurion 7 B12; Model Numbers: 722067, 722225. 6. Azurion 7 B20; Model Numbers: 722068, 722226. 7. Azurion 7 M12; Model Numbers: 722078, 722223. 8. Azurion 7 M20; Model Numbers: 722079, 722224, 722282. Interventional Fluoroscopic X-Ray System.
Codes / lots: 1. Model Numbers (UDI Numbers): 722063 ((01)00884838085275(21)56, (01)00884838085275(21)96, (01)00884838085275(21)98, (01)00884838085275(21)80, (01)00884838085275(21)146, (01)00884838085275(21)3, (01)00884838085275(21)22, (01)00884838085275(21)153, (01)00884838085275(21)40, (01)00884838085275(21)70, (01)00884838085275(21)30, (01)00884838085275(21)19, (01)00884838085275(21)121, (01)00884838085275(21)18, (01)00884838085275(21)16, (01)00884838085275(21)14, (01)00884838085275(21)17, (01)00884838085275(21)53, (01)00884838085275(21)101, (01)00884838085275(21)143, (01)00884838085275(21)41, (01)00884838085275(21)104, (01)00884838085275(21)151, (01)00884838085275(21)137, (01)00884838085275(21)73, (01)00884838085275(21)150, (01)00884838085275(21)105, (01)00884838085275(21)129, (01)00884838085275(21)59, (01)00884838085275(21)154, (01)00884838085275(21)75, (01)00884838085275(21)94, (01)00884838085275(21)26, (01)00884838085275(21)106, (01)00884838085275(21)135, (01)00884838085275(21)123, (01)00884838085275(21)89, (01)00884838085275(21)79, (01)00884838085275(21)133, (01)00884838085275(21)81, (01)00884838085275(21)140, (01)00884838085275(21)52, (01)00884838085275(21)48…
Reason for recall
Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized Hard Disk Drives.
FDA-determined cause: Under Investigation by firm
Action taken
Philips notified consignees on about 06/17/2026 via letter sent certified mail titled, URGENT Medical Device Correction. Consignees were instructed to circulate the notification letter to all users of the system for awareness and to follow the instructions. In the case motorized movements are unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2) and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually, when the table is not tilted. Additionally, consignees were instructed to provide a copy of the notification letter to any organizations to which affected units have been transferred to, to keep the notification letter with system documentation until the correction is complete and complete and return the provided response form. Philips will inspect all affected systems and replace HDDs that are not according to the specifications, as well as correct configurations where different HDD types are used within a single system. Philips expects to start the implementation of this correction in September 2026.
Details
- Recall number
- Z-2892-2026
- Initiated
- June 17, 2026
- Posted by FDA
- August 5, 2026
- Product code
- OWB – Interventional Fluoroscopic X-Ray System
- Quantity
- 3,341 units
- Distribution
- US Nationwide distribution.
- Recalling firm
- Philips Medical Systems Nederland B.V., Best
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2891-2026 Class II | Philips Allura under the following System Descriptions and corresponding model numbers:…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | 06/17/2026Open, Classified |
| Z-2893-2026 Class II | Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional…Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unauthorized… | 06/17/2026Open, Classified |