Z-2289-2026 Class II Ongoing
FDA device recall Z-2289-2026 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: 156 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2026
- Initiation Date
- December 7, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Product Quantity
- 156 units
Product Description
Philips Azurion 7B20/15, Model Numbers: 722068, 722226 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
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