Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

Class I - Dangerous

🏥 Medical Devices Recalled: February 6, 2024 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Diagnostic Equipment Nationwide

What Should You Do?

Check if you have this product:
US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)1518 1317 (01)00884838099258(21)1317 1221 (01)00884838099258(21)1221 845 (01)00884838099258(21)845 974 (01)00884838099258(21)974 905 (01)00884838099258(21)905 (3) Model: 722225 227 (01)00884838099265(21)227 (4) Model: 722226 441 (01)00884838099272(21)441 398 (01)00884838099272(21)398 OUS: 179 (01)00884838099265(21)179 145 (01)00884838099265(21)145 223 (01)00884838099265(21)223 226 (01)00884838099265(21)226 232 (01)00884838099265(21)232 196 (01)00884838099265(21)196 159 (01)00884838099265(21)159 200 (01)00884838099265(21)200 234 (01)00884838099265(21)234 206 (01)00884838099265(21)206. 412 (01)00884838099272(21)412 425 (01)00884838099272(21)425 420 (01)00884838099272(21)420 355 (01)00884838099272(21)355 393 (01)00884838099272(21)393 407 (01)00884838099272(21)407 402 (01)00884838099272(21)402 527 (01)00884838099272(21)527 479 (01)00884838099272(21)479 509 (01)00884838099272(21)509 460 (01)00884838099272(21)460 505 (01)00884838099272(21)505 513 (01)00884838099272(21)513 485 (01)00884838099272(21)485 364 (01)00884838099272(21)364 507 (01)00884838099272(21)507 577 (01)00884838099272(21)577 476 (01)00884838099272(21)476 515 (01)00884838099272(21)515 596 (01)00884838099272(21)596 598 (01)00884838099272(21)598 521 (01)00884838099272(21)521 455 (01)00884838099272(21)455 589 (01)00884838099272(21)589 575 (01)00884838099272(21)575 522 (01)00884838099272(21)522 540 (01)00884838099272(21)540. 506 (01)00884838099241(21)506 550 (01)00884838099241(21)550 613 (01)00884838099241(21)613 121 (01)00884838099241(21)121 630 (01)00884838099241(21)630 474 (01)00884838099241(21)474 614 (01)00884838099241(21)614 612 (01)00884838099241(21)612 523 (01)00884838099241(21)523 517 (01)00884838099241(21)517 554 (01)00884838099241(21)554 450 (01)00884838099241(21)450 542 (01)00884838099241(21)542 623 (01)00884838099241(21)623 475 (01)00884838099241(21)475 547 (01)00884838099241(21)547 397 (01)00884838099241(21)397 586 (01)00884838099241(21)586 42 (01)00884838099241(21)42 492 (01)00884838099241(21)492 427 (01)00884838099241(21)427 520 (01)00884838099241(21)520 708 (01)00884838099241(21)708 524 (01)00884838099241(21)524 497 (01)00884838099241(21)497 519 (01)00884838099241(21)519 394 (01)00884838099241(21)394 600 (01)00884838099241(21)600. 1154 (01)00884838099258(21)1154 1438 (01)00884838099258(21)1438 1351 (01)00884838099258(21)1351 1139 (01)00884838099258(21)1139 1326 (01)00884838099258(21)1326 1391 (01)00884838099258(21)1391 1075 (01)00884838099258(21)1075 1281 (01)00884838099258(21)1281 1497 (01)00884838099258(21)1497 802 (01)00884838099258(21)802 1553 (01)00884838099258(21)1553 1401 (01)00884838099258(21)1401 1348 (01)00884838099258(21)1348 1350 (01)00884838099258(21)1350 1367 (01)00884838099258(21)1367 1407 (01)00884838099258(21)1407 1181 (01)00884838099258(21)1181 1365 (01)00884838099258(21)1365 1503 (01)00884838099258(21)1503 455 (01)00884838099258(21)455 1489 (01)00884838099258(21)1489 1342 (01)00884838099258(21)1342 1666 (01)00884838099258(21)1666 1714 (01)00884838099258(21)1714 1673 (01)00884838099258(21)1673 1658 (01)00884838099258(21)1658 1733 (01)00884838099258(21)1733 1741 (01)00884838099258(21)1741 1173 (01)00884838099258(21)1173 1566 (01)00884838099258(21)1566 915 (01)00884838099258(21)915 1713 (01)00884838099258(21)1713 1688 (01)00884838099258(21)1688 936 (01)00884838099258(21)936 1602 (01)00884838099258(21)1602 1588 (01)00884838099258(21)1588 1193 (01)00884838099258(21)1193 1586 (01)00884838099258(21)1586 1665 (01)00884838099258(21)1665 1609 (01)00884838099258(21)1609 1463 (01)00884838099258(21)1463 969 (01)00884838099258(21)969 1280 (01)00884838099258(21)1280 1402 (01)00884838099258(21)1402 1598 (01)00884838099258(21)1598 1624 (01)00884838099258(21)1624 1537 (01)00884838099258(21)1537 1645 (01)00884838099258(21)1645 1355 (01)00884838099258(21)1355 1349 (01)00884838099258(21)1349 1736 (01)00884838099258(21)1736 1505 (01)00884838099258(21)1505 1664 (01)00884838099258(21)1664 1711 (01)00884838099258(21)1711 1862 (01)00884838099258(21)1862 1708 (01)00884838099258(21)1708 1447 (01)00884838099258(21)1447 1786 (01)00884838099258(21)1786 1428 (01)00884838099258(21)1428
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:: Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) in PoInt EVR (Power Invertor). If a short circuit occurs, it will cause the fuses to trip and the system will become non-functional due to power loss, resulting in a potential delay of procedure or termination of procedure.
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 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

Product Codes/Lot Numbers:

US: (1) Model 722223 SN: 580 (01)00884838099241(21)580 (2) Model: 722224 SN: UDI: 1518 (01)00884838099258(21)1518 1317 (01)00884838099258(21)1317 1221 (01)00884838099258(21)1221 845 (01)00884838099258(21)845 974 (01)00884838099258(21)974 905 (01)00884838099258(21)905 (3) Model: 722225 227 (01)00884838099265(21)227 (4) Model: 722226 441 (01)00884838099272(21)441 398 (01)00884838099272(21)398 OUS: 179 (01)00884838099265(21)179 145 (01)00884838099265(21)145 223 (01)00884838099265(21)223 226 (01)00884838099265(21)226 232 (01)00884838099265(21)232 196 (01)00884838099265(21)196 159 (01)00884838099265(21)159 200 (01)00884838099265(21)200 234 (01)00884838099265(21)234 206 (01)00884838099265(21)206. 412 (01)00884838099272(21)412 425 (01)00884838099272(21)425 420 (01)00884838099272(21)420 355 (01)00884838099272(21)355 393 (01)00884838099272(21)393 407 (01)00884838099272(21)407 402 (01)00884838099272(21)402 527 (01)00884838099272(21)527 479 (01)00884838099272(21)479 509 (01)00884838099272(21)509 460 (01)00884838099272(21)460 505 (01)00884838099272(21)505 513 (01)00884838099272(21)513 485 (01)00884838099272(21)485 364 (01)00884838099272(21)364 507 (01)00884838099272(21)507 577 (01)00884838099272(21)577 476 (01)00884838099272(21)476 515 (01)00884838099272(21)515 596 (01)00884838099272(21)596 598 (01)00884838099272(21)598 521 (01)00884838099272(21)521 455 (01)00884838099272(21)455 589 (01)00884838099272(21)589 575 (01)00884838099272(21)575 522 (01)00884838099272(21)522 540 (01)00884838099272(21)540. 506 (01)00884838099241(21)506 550 (01)00884838099241(21)550 613 (01)00884838099241(21)613 121 (01)00884838099241(21)121 630 (01)00884838099241(21)630 474 (01)00884838099241(21)474 614 (01)00884838099241(21)614 612 (01)00884838099241(21)612 523 (01)00884838099241(21)523 517 (01)00884838099241(21)517 554 (01)00884838099241(21)554 450 (01)00884838099241(21)450 542 (01)00884838099241(21)542 623 (01)00884838099241(21)623 475 (01)00884838099241(21)475 547 (01)00884838099241(21)547 397 (01)00884838099241(21)397 586 (01)00884838099241(21)586 42 (01)00884838099241(21)42 492 (01)00884838099241(21)492 427 (01)00884838099241(21)427 520 (01)00884838099241(21)520 708 (01)00884838099241(21)708 524 (01)00884838099241(21)524 497 (01)00884838099241(21)497 519 (01)00884838099241(21)519 394 (01)00884838099241(21)394 600 (01)00884838099241(21)600. 1154 (01)00884838099258(21)1154 1438 (01)00884838099258(21)1438 1351 (01)00884838099258(21)1351 1139 (01)00884838099258(21)1139 1326 (01)00884838099258(21)1326 1391 (01)00884838099258(21)1391 1075 (01)00884838099258(21)1075 1281 (01)00884838099258(21)1281 1497 (01)00884838099258(21)1497 802 (01)00884838099258(21)802 1553 (01)00884838099258(21)1553 1401 (01)00884838099258(21)1401 1348 (01)00884838099258(21)1348 1350 (01)00884838099258(21)1350 1367 (01)00884838099258(21)1367 1407 (01)00884838099258(21)1407 1181 (01)00884838099258(21)1181 1365 (01)00884838099258(21)1365 1503 (01)00884838099258(21)1503 455 (01)00884838099258(21)455 1489 (01)00884838099258(21)1489 1342 (01)00884838099258(21)1342 1666 (01)00884838099258(21)1666 1714 (01)00884838099258(21)1714 1673 (01)00884838099258(21)1673 1658 (01)00884838099258(21)1658 1733 (01)00884838099258(21)1733 1741 (01)00884838099258(21)1741 1173 (01)00884838099258(21)1173 1566 (01)00884838099258(21)1566 915 (01)00884838099258(21)915 1713 (01)00884838099258(21)1713 1688 (01)00884838099258(21)1688 936 (01)00884838099258(21)936 1602 (01)00884838099258(21)1602 1588 (01)00884838099258(21)1588 1193 (01)00884838099258(21)1193 1586 (01)00884838099258(21)1586 1665 (01)00884838099258(21)1665 1609 (01)00884838099258(21)1609 1463 (01)00884838099258(21)1463 969 (01)00884838099258(21)969 1280 (01)00884838099258(21)1280 1402 (01)00884838099258(21)1402 1598 (01)00884838099258(21)1598 1624 (01)00884838099258(21)1624 1537 (01)00884838099258(21)1537 1645 (01)00884838099258(21)1645 1355 (01)00884838099258(21)1355 1349 (01)00884838099258(21)1349 1736 (01)00884838099258(21)1736 1505 (01)00884838099258(21)1505 1664 (01)00884838099258(21)1664 1711 (01)00884838099258(21)1711 1862 (01)00884838099258(21)1862 1708 (01)00884838099258(21)1708 1447 (01)00884838099258(21)1447 1786 (01)00884838099258(21)1786 1428 (01)00884838099258(21)1428

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1178-2024

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