ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Class I - DangerousWhat Should You Do?
- Check if you have this product: (1) System Code: 722015; UDI: N/A; System Serial Number: 12, 16, 2, 8, 23, 3, 13; (2) System Code: 722023; UDI: 00884838059085; System Serial Number: 49, 41, 142, 110, 12, 179, 124, 27, 98, 66, 118, 117, 138, 42, 64, 116, 127, 175, 75, 82, 83, 46, 35, 109, 146, 33, 165, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 158, 5, 86, 34, 132, 9, 108, 121, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 87, 94, 57, 125, 73, 106, 67, 16, 96, 58, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150; (3) System Code: 722035; UDI: 00884838054240; System Serial Number: 119, 126, 169, 72, 124, 161, 183, 242, 245, 246, 46, 196, 52, 236, 147, 172, 123, 74, 59, 60, 88, 30, 216, 212, 85, 21, 47, 222, 121, 131, 145, 127, 38, 187, 243, 143, 244, 125, 117, 100, 57, 247, 34, 165, 252, 101, 89, 192, 111, 128, 227, 144, 174, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 83, 53, 32, 164, 56, 40, 10, 11, 62, 265, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 151, 92, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202;
- 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:
- Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
Product Codes/Lot Numbers:
(1) System Code: 722015; UDI: N/A; System Serial Number: 12, 16, 2, 8, 23, 3, 13; (2) System Code: 722023; UDI: 00884838059085; System Serial Number: 49, 41, 142, 110, 12, 179, 124, 27, 98, 66, 118, 117, 138, 42, 64, 116, 127, 175, 75, 82, 83, 46, 35, 109, 146, 33, 165, 169, 101, 103, 129, 10, 105, 90, 107, 100, 47, 159, 137, 119, 164, 70, 95, 177, 158, 5, 86, 34, 132, 9, 108, 121, 31, 112, 173, 114, 170, 172, 4, 14, 85, 13, 88, 25, 87, 94, 57, 125, 73, 106, 67, 16, 96, 58, 38, 141, 32, 84, 68, 134, 79, 52, 56, 69, 37, 21, 53, 123, 157, 102, 126, 145, 144, 15, 135, 152, 149, 60, 150; (3) System Code: 722035; UDI: 00884838054240; System Serial Number: 119, 126, 169, 72, 124, 161, 183, 242, 245, 246, 46, 196, 52, 236, 147, 172, 123, 74, 59, 60, 88, 30, 216, 212, 85, 21, 47, 222, 121, 131, 145, 127, 38, 187, 243, 143, 244, 125, 117, 100, 57, 247, 34, 165, 252, 101, 89, 192, 111, 128, 227, 144, 174, 28, 84, 130, 263, 132, 25, 98, 134, 35, 226, 190, 3, 6, 1, 249, 109, 251, 207, 158, 160, 237, 163, 79, 248, 253, 94, 80, 250, 154, 69, 97, 148, 170, 195, 26, 122, 96, 107, 142, 58, 166, 235, 230, 83, 53, 32, 164, 56, 40, 10, 11, 62, 265, 221, 257, 255, 229, 256, 254, 261, 260, 238, 113, 258, 241, 188, 259, 267, 167, 204, 43, 33, 37, 104, 233, 114, 108, 153, 70, 65, 191, 77, 110, 225, 75, 76, 193, 185, 186, 129, 103, 71, 151, 92, 201, 208, 149, 205, 19, 50, 51, 61, 211, 99, 12, 15, 198, 82, 105, 136, 194, 23, 200, 116, 48, 13, 106, 95, 206, 168, 203, 146, 81, 156, 45, 173, 49, 64, 171, 184, 102, 17, 215, 29, 231, 16, 202;
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1665-2026
Related Recalls
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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.
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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.