Z-2285-2026 Class II Ongoing
FDA device recall Z-2285-2026 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on December 7, 2023 and is designated Class II. Reason for recall: During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitc… The recall status is ongoing. Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- December 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Product Quantity
- 27 units
Product Description
Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key
Reason for Recall
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.
Distribution Pattern
US Nationwide distribution.
Code Information
UDI (01)00884838085282(21)209, (01)00884838099210(21)100, (01)00884838099210(21)254, (01)00884838099210(21)256, (01)00884838099210(21)257, (01)00884838099210(21)265, (01)00884838099210(21)255, (01)00884838099210(21)99, (01)00884838085282(21)260, (01)00884838085282(21)261, (01)00884838099210(21)69, (01)00884838099210(21)12, (01)00884838085282(21)314, (01)00884838085282(21)259, (01)00884838099210(21)15, (01)00884838099210(21)19, (01)00884838099210(21)23, (01)00884838099210(21)17, (01)00884838085282(21)258, (01)00884838099210(21)55, (01)00884838099210(21)45, (01)00884838085282(21)270, (01)00884838099210(21)187, (01)00884838099210(21)223, (01)00884838099210(21)44, (01)00884838099210(21)113, (01)00884838099210(21)112.