Philips Azurion 7M20, Model Numbers: 722079, 722224 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)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)00884838099258(21)275, (01)00884838099258(21)277, (01)00884838099258(21)295, (01)00884838099258(21)272, (01)00884838099258(21)261, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838099258(21)1315, (01)00884838099258(21)381, (01)00884838099258(21)959, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838085268(21)460, (01)00884838085268(21)1387, (01)00884838099258(21)260, (01)00884838099258(21)1019, (01)00884838099258(21)1371, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838099258(21)1049, (01)00884838099258(21)1484, (01)00884838099258(21)1083, (01)00884838085268(21)703307, (01)00884838099258(21)246, (01)00884838099258(21)475.
- 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 7M20, Model Numbers: 722079, 722224 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)00884838099258(21)450, (01)00884838099258(21)750, (01)00884838099258(21)409, (01)00884838099258(21)262, (01)00884838099258(21)275, (01)00884838099258(21)277, (01)00884838099258(21)295, (01)00884838099258(21)272, (01)00884838099258(21)261, (01)00884838099258(21)630, (01)00884838099258(21)1003, (01)00884838099258(21)1315, (01)00884838099258(21)381, (01)00884838099258(21)959, (01)00884838085268(21)1013, (01)00884838085268(21)1412, (01)00884838099258(21)232, (01)00884838085268(21)460, (01)00884838085268(21)1387, (01)00884838099258(21)260, (01)00884838099258(21)1019, (01)00884838099258(21)1371, (01)00884838085268(21)40, (01)00884838085268(21)43, (01)00884838085268(21)35, (01)00884838099258(21)1049, (01)00884838099258(21)1484, (01)00884838099258(21)1083, (01)00884838085268(21)703307, (01)00884838099258(21)246, (01)00884838099258(21)475.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2291-2026
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 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
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.