Philips Azurion 7B12/12, Model Numbers: 722067, 722225 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
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI (01)00884838099265(21)104, (01)00884838085350(21)221, (01)00884838099265(21)153, (01)00884838099265(21)46, (01)00884838099265(21)28, (01)00884838085350(21)250, (01)00884838099265(21)72, (01)00884838099265(21)208, (01)00884838099265(21)41, (01)00884838099265(21)122, (01)00884838099265(21)147, (01)00884838085350(21)225, (01)00884838099265(21)262, (01)00884838099265(21)112, (01)00884838099265(21)110, (01)00884838099265(21)207, (01)00884838099265(21)68, (01)00884838099265(21)177, (01)00884838099265(21)29, (01)00884838099265(21)71, (01)00884838099265(21)37, (01)00884838099265(21)175, (01)00884838099265(21)148, (01)00884838099265(21)205, , (01)00884838099265(21)229, (01)00884838099265(21)228, (01)00884838085350(21)277, (01)00884838085350(21)115, (01)00884838099265(21)157, (01)00884838085350(21)163, (01)00884838099265(21)268, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)208, (01)00884838085350(21)104, (01)00884838085350(21)244, (01)00884838085350(21)234, (01)00884838099265(21)53, (01)00884838099265(21)259, (01)00884838099265(21)55, (01)00884838099265(21)235, (01)00884838099265(21)298, (01)00884838085350(21)70, (01)00884838099265(21)233, (01)00884838099265(21)141, (01)00884838099265(21)289, (01)00884838099265(21)249, (01)00884838099265(21)84, (01)00884838099265(21)111, (01)00884838099265(21)227.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 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
Product Codes/Lot Numbers:
UDI (01)00884838099265(21)104, (01)00884838085350(21)221, (01)00884838099265(21)153, (01)00884838099265(21)46, (01)00884838099265(21)28, (01)00884838085350(21)250, (01)00884838099265(21)72, (01)00884838099265(21)208, (01)00884838099265(21)41, (01)00884838099265(21)122, (01)00884838099265(21)147, (01)00884838085350(21)225, (01)00884838099265(21)262, (01)00884838099265(21)112, (01)00884838099265(21)110, (01)00884838099265(21)207, (01)00884838099265(21)68, (01)00884838099265(21)177, (01)00884838099265(21)29, (01)00884838099265(21)71, (01)00884838099265(21)37, (01)00884838099265(21)175, (01)00884838099265(21)148, (01)00884838099265(21)205, , (01)00884838099265(21)229, (01)00884838099265(21)228, (01)00884838085350(21)277, (01)00884838085350(21)115, (01)00884838099265(21)157, (01)00884838085350(21)163, (01)00884838099265(21)268, (01)00884838085350(21)75, (01)00884838085350(21)132, (01)00884838085350(21)147, (01)00884838085350(21)208, (01)00884838085350(21)104, (01)00884838085350(21)244, (01)00884838085350(21)234, (01)00884838099265(21)53, (01)00884838099265(21)259, (01)00884838099265(21)55, (01)00884838099265(21)235, (01)00884838099265(21)298, (01)00884838085350(21)70, (01)00884838099265(21)233, (01)00884838099265(21)141, (01)00884838099265(21)289, (01)00884838099265(21)249, (01)00884838099265(21)84, (01)00884838099265(21)111, (01)00884838099265(21)227.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2288-2026
Related Recalls
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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Philips Azurion 3M12, Model Numbers: 722063, 722221 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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.
Philips Azurion 7M12, Model Numbers: 722078, 722223 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
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
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.