Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Class I - DangerousWhat Should You Do?
- Check if you have this product: (1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1005, 866, 1361, 952, 1241, 1169, 756, 703351, 1135, 1122, 824, 748, 630, 638, 703385, 812, 703346, 1303, 1313, 893, 768, 929, 703638, 1357, 703810, 934, 1202, 703461, 703706, 1172, 703959, 703845, 703705; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 539, 395, 278, 134, 730, 252, 370, 36, 572, 645, 272, 495, 781, 62, 1388, 352, 1655, 690, 555, 895, 2165, 861, 60, 20, 648, 2231, 1778, 1431, 778, 477, 917, 1718, 388, 2042, 150, 764, 2036, 1421, 157, 879, 212, 144, 1463, 347, 575, 2187, 355, 2576, 1332, 424, 387, 863, 211, 474, 712, 549, 2309, 799, 2283, 639, 1700, 2071, 537, 1589, 2208, 2057, 771, 772, 1216, 1667;
- 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.
โ ๏ธ 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:
- Loss of connectivity between the FlexArm and the Table due to a software issue related to the date/time format. This connection issue leads to a loss of movement of the arm or table.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Azurion 7 M20 FlexArm system (Software version R2.x) with Maquet Magnus Table (Software version 05.02.12)
Product Codes/Lot Numbers:
(1) System Code: 722079; (1) UDI/DI: 00884838085268; (1) Serial Number: 1005, 866, 1361, 952, 1241, 1169, 756, 703351, 1135, 1122, 824, 748, 630, 638, 703385, 812, 703346, 1303, 1313, 893, 768, 929, 703638, 1357, 703810, 934, 1202, 703461, 703706, 1172, 703959, 703845, 703705; (2) System Code: 722224; (2) UDI/DI: 00884838099258; (2) Serial Number: 539, 395, 278, 134, 730, 252, 370, 36, 572, 645, 272, 495, 781, 62, 1388, 352, 1655, 690, 555, 895, 2165, 861, 60, 20, 648, 2231, 1778, 1431, 778, 477, 917, 1718, 388, 2042, 150, 764, 2036, 1421, 157, 879, 212, 144, 1463, 347, 575, 2187, 355, 2576, 1332, 424, 387, 863, 211, 474, 712, 549, 2309, 799, 2283, 639, 1700, 2071, 537, 1589, 2208, 2057, 771, 772, 1216, 1667;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0861-2024
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.