Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-2287-2026

Z-2287-2026 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

FDA device recall Z-2287-2026 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: 51 units.

Recall Details

Product Type: Devices
Report Date: June 10, 2026
Initiation Date: December 7, 2023
Termination Date: N/A
Voluntary/Mandated
Product Quantity: 51 units

Product Description

Philips Azurion 5M20, Model Numbers: 722228 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)00884838099234(21)67, (01)00884838099234(21)49, (01)00884838099234(21)10, (01)00884838099234(21)36, (01)00884838099234(21)64, (01)00884838099234(21)110, (01)00884838099234(21)328, (01)00884838099234(21)149, (01)00884838099234(21)213, (01)00884838099234(21)45, (01)00884838099234(21)159, (01)00884838099234(21)18, (01)00884838099234(21)231, (01)00884838099234(21)61, (01)00884838099234(21)204, (01)00884838099234(21)273, (01)00884838099234(21)76, (01)00884838099234(21)150, (01)00884838099234(21)132, (01)00884838099234(21)189, (01)00884838099234(21)17, (01)00884838099234(21)47, (01)00884838099234(21)38, (01)00884838099234(21)87, (01)00884838099234(21)128, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)181, (01)00884838099234(21)177, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)79, (01)00884838099234(21)80, (01)00884838099234(21)157, (01)00884838099234(21)24, (01)00884838099234(21)187, (01)00884838099234(21)26, (01)00884838099234(21)29, (01)00884838099234(21)122, (01)00884838099234(21)127, (01)00884838099234(21)6, (01)00884838099234(21)123, (01)00884838099234(21)124, (01)00884838099234(21)92, (01)00884838099234(21)215, (01)00884838099234(21)91, (01)00884838099234(21)205, (01)00884838099234(21)20, (01)00884838099234(21)37a.

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