| | Class 2 Device Recall Azurion 7 B20 |  |
| Date Initiated by Firm | October 06, 2026 |
|---|
| Date Posted | October 27, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0297-2027 |
|---|
| Recall Event ID |
99939 |
| 510(K)Number | K172822 K181830 K200917 |
|---|
| Product Classification |
Interventional fluoroscopic x-ray system - Product Code OWB
|
| Product | Philips Azurion 7 B20. Model Numbers: 722068, 722226. |
|---|
| Code Information |
1. Model Number: 722068. UDI Numbers: (01)00884838085367(21)178, (01)00884838085367(21)147, (01)00884838085367(21)205, (01)00884838085367(21)170, (01)00884838085367(21)494, (01)00884838085367(21)247, (01)00884838085367(21)149, (01)00884838085367(21)153, (01)00884838085367(21)85, (01)00884838085367(21)320, (01)00884838085367(21)89, (01)00884838085367(21)172, (01)00884838085367(21)505, (01)00884838085367(21)271, (01)00884838085367(21)443, (01)00884838085367(21)354, (01)00884838085367(21)196, (01)00884838085367(21)73, (01)00884838085367(21)285, (01)00884838085367(21)406, (01)00884838085367(21)528, (01)00884838085367(21)350, (01)00884838085367(21)462, (01)00884838085367(21)319, (01)00884838085367(21)520, (01)00884838085367(21)117, (01)00884838085367(21)143, (01)00884838085367(21)84, (01)00884838085367(21)469, (01)00884838085367(21)361, (01)00884838085367(21)114, (01)00884838085367(21)477, (01)00884838085367(21)232, (01)00884838085367(21)107, (01)00884838085367(21)282, (01)00884838085367(21)276, (01)00884838085367(21)608, (01)00884838085367(21)473, (01)00884838085367(21)417, (01)00884838085367(21)302, (01)00884838085367(21)88, (01)00884838085367(21)126, (01)00884838085367(21)211, (01)00884838085367(21)468, (01)00884838085367(21)410, (01)00884838085367(21)466, (01)00884838085367(21)495, (01)00884838085367(21)167, (01)00884838085367(21)537, (01)00884838085367(21)173, (01)00884838085367(21)289, (01)00884838085367(21)233, (01)00884838085367(21)536, (01)00884838085367(21)204, (01)00884838085367(21)313, (01)00884838085367(21)237, (01)00884838085367(21)133, (01)00884838085367(21)481, (01)00884838085367(21)307, (01)00884838085367(21)577, (01)00884838085367(21)210, (01)00884838085367(21)258, (01)00884838085367(21)328, (01)00884838085367(21)199, (01)00884838085367(21)480, (01)00884838085367(21)72, (01)00884838085367(21)491, (01)00884838085367(21)423, (01)00884838085367(21)509, (01)00884838085367(21)246, (01)00884838085367(21)614, (01)00884838085367(21)539, (01)00884838085367(21)257, (01)00884838085367(21)369, (01)00884838085367(21)508, (01)00884838085367(21)97, (01)00884838085367(21)303, (01)00884838085367(21)48, (01)00884838085367(21)44, (01)00884838085367(21)550, (01)00884838085367(21)460, (01)00884838085367(21)551, (01)00884838085367(21)478, (01)00884838085367(21)522, (01)00884838085367(21)238, (01)00884838085367(21)544, (01)00884838085367(21)230, (01)00884838085367(21)434, (01)00884838085367(21)93, (01)00884838085367(21)306, (01)00884838085367(21)192, (01)00884838085367(21)215, (01)00884838085367(21)447, (01)00884838085367(21)316, (01)00884838085367(21)552, (01)00884838085367(21)570, (01)00884838085367(21)387, (01)00884838085367(21)134, (01)00884838085367(21)560, (01)00884838085367(21)158, (01)00884838085367(21)518, (01)00884838085367(21)318, (01)00884838085367(21)250, (01)00884838085367(21)118, (01)00884838085367(21)185, (01)00884838085367(21)206, (01)00884838085367(21)489, (01)00884838085367(21)521, (01)00884838085367(21)254, (01)00884838085367(21)534, 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(01)00884838085367(21)475, (01)00884838085367(21)180, (01)00884838085367(21)414, (01)00884838085367(21)349, (01)00884838085367(21)519, (01)00884838085367(21)234, (01)00884838085367(21)219, (01)00884838085367(21)195, (01)00884838085367(21)533, (01)00884838085367(21)398, (01)00884838085367(21)618, (01)00884838085367(21)549, (01)00884838085367(21)46, (01)00884838085367(21)531, (01)00884838085367(21)426, (01)00884838085367(21)290, (01)00884838085367(21)49, (01)00884838085367(21)326, (01)00884838085367(21)286, (01)00884838085367(21)124, (01)00884838085367(21)362, (01)00884838085367(21)317, (01)00884838085367(21)571, (01)00884838085367(21)331, (01)00884838085367(21)273, (01)00884838085367(21)188, (01)00884838085367(21)264, (01)00884838085367(21)122, (01)00884838085367(21)300, (01)00884838085367(21)100, (01)00884838085367(21)253, (01)00884838085367(21)391, (01)00884838085367(21)226, (01)00884838085367(21)315, (01)00884838085367(21)63, (01)00884838085367(21)252, (01)00884838085367(21)175, (01)00884838085367(21)186, (01)00884838085367(21)409, (01)00884838085367(21)298, (01)00884838085367(21)368. Serial Numbers: 178, 147, 205, 170, 494, 247, 149, 153, 85, 320, 89, 172, 505, 271, 443, 354, 196, 73, 285, 406, 528, 350, 462, 319, 520, 117, 143, 84, 469, 361, 114, 477, 232, 107, 282, 276, 608, 473, 417, 302, 88, 126, 211, 468, 410, 466, 495, 167, 537, 173, 289, 233, 536, 204, 313, 237, 133, 481, 307, 577, 210, 258, 328, 199, 480, 72, 491, 423, 509, 246, 614, 539, 257, 369, 508, 97, 303, 48, 44, 550, 460, 551, 478, 522, 238, 544, 230, 434, 93, 306, 192, 215, 447, 316, 552, 570, 387, 134, 560, 158, 518, 318, 250, 118, 185, 206, 489, 521, 254, 534, 292, 497, 293, 359, 527, 129, 128, 396, 334, 425, 415, 471, 540, 584, 553, 602, 240, 617, 604, 589, 612, 556, 557, 574, 603, 601, 609, 616, 597, 605, 575, 516, 624, 563, 590, 548, 420, 475, 180, 414, 349, 519, 234, 219, 195, 533, 398, 618, 549, 46, 531, 426, 290, 49, 326, 286, 124, 362, 317, 571, 331, 273, 188, 264, 122, 300, 100, 253, 391, 226, 315, 63, 252, 175, 186, 409, 298, 368.
2. Model Number: 722226. UDI Numbers: (01)00884838099272(21)209, (01)00884838099272(21)675, (01)00884838099272(21)1091, (01)00884838099272(21)113, (01)00884838099272(21)1145, (01)00884838099272(21)1078, (01)00884838099272(21)197, (01)00884838099272(21)687, (01)00884838099272(21)680, (01)00884838099272(21)280, (01)00884838099272(21)343, (01)00884838099272(21)98, (01)00884838099272(21)332, (01)00884838099272(21)341, (01)00884838099272(21)1162, (01)00884838099272(21)554, (01)00884838099272(21)337, (01)00884838099272(21)400, (01)00884838099272(21)757, (01)00884838099272(21)326, (01)00884838099272(21)323, (01)00884838099272(21)262, (01)00884838099272(21)1017, (01)00884838099272(21)379, (01)00884838099272(21)786, (01)00884838099272(21)462, (01)00884838099272(21)573, (01)00884838099272(21)458, (01)00884838099272(21)987, (01)00884838099272(21)880, (01)00884838099272(21)141, (01)00884838099272(21)693, (01)00884838099272(21)510, (01)00884838099272(21)882, (01)00884838099272(21)1157, (01)00884838099272(21)21, (01)00884838099272(21)1050, (01)00884838099272(21)367, (01)00884838099272(21)184, (01)00884838099272(21)178, (01)00884838099272(21)179, (01)00884838099272(21)250, (01)00884838099272(21)1139, (01)00884838099272(21)1062, (01)00884838099272(21)575, (01)00884838099272(21)1121, (01)00884838099272(21)950, (01)00884838099272(21)368, (01)00884838099272(21)176, (01)00884838099272(21)712, (01)00884838099272(21)829, (01)00884838099272(21)249, (01)00884838099272(21)576, (01)00884838099272(21)1046, (01)00884838099272(21)708, (01)00884838099272(21)738, (01)00884838099272(21)1083, (01)00884838099272(21)1098, (01)00884838099272(21)717, (01)00884838099272(21)1126, (01)00884838099272(21)665, (01)00884838099272(21)764, (01)00884838099272(21)386, (01)00884838099272(21)977, (01)00884838099272(21)721, (01)00884838099272(21)1006, (01)00884838099272(21)232, (01)00884838099272(21)682, (01)00884838099272(21)789, (01)00884838099272(21)698, (01)00884838099272(21)331, (01)00884838099272(21)1097, (01)00884838099272(21)1094, (01)00884838099272(21)378, (01)00884838099272(21)808, (01)00884838099272(21)718, (01)00884838099272(21)195, (01)00884838099272(21)412, (01)00884838099272(21)715, (01)00884838099272(21)1143, (01)00884838099272(21)775, (01)00884838099272(21)1073, (01)00884838099272(21)982, (01)00884838099272(21)282, (01)00884838099272(21)617, (01)00884838099272(21)958, (01)00884838099272(21)222, (01)00884838099272(21)430, (01)00884838099272(21)1067, (01)00884838099272(21)810, (01)00884838099272(21)1114, (01)00884838099272(21)314, (01)00884838099272(21)762, (01)00884838099272(21)1102, (01)00884838099272(21)359, (01)00884838099272(21)978, (01)00884838099272(21)1060, (01)00884838099272(21)920, (01)00884838099272(21)1136, (01)00884838099272(21)836, (01)00884838099272(21)835, (01)00884838099272(21)795, (01)00884838099272(21)800, (01)00884838099272(21)899, (01)00884838099272(21)838, (01)00884838099272(21)944, (01)00884838099272(21)1123, (01)00884838099272(21)335, (01)00884838099272(21)1039, (01)00884838099272(21)203, (01)00884838099272(21)731, (01)00884838099272(21)725, (01)00884838099272(21)701, (01)00884838099272(21)967, (01)00884838099272(21)501, (01)00884838099272(21)992, (01)00884838099272(21)119, (01)00884838099272(21)732, (01)00884838099272(21)974, (01)00884838099272(21)919, (01)00884838099272(21)605, (01)00884838099272(21)686, (01)00884838099272(21)230, (01)00884838099272(21)523, (01)00884838099272(21)327, (01)00884838099272(21)477, (01)00884838099272(21)1049, (01)00884838099272(21)298, (01)00884838099272(21)993, (01)00884838099272(21)522, (01)00884838099272(21)520, (01)00884838099272(21)521, (01)00884838099272(21)259, (01)00884838099272(21)909, (01)00884838099272(21)142, (01)00884838099272(21)263, (01)00884838099272(21)422, (01)00884838099272(21)17, (01)00884838099272(21)1057, (01)00884838099272(21)36, (01)00884838099272(21)1103, (01)00884838099272(21)164, (01)00884838099272(21)485, (01)00884838099272(21)1155, (01)00884838099272(21)1054, (01)00884838099272(21)366, (01)00884838099272(21)1140, (01)00884838099272(21)1048, (01)00884838099272(21)752, (01)00884838099272(21)1088, (01)00884838099272(21)47, (01)00884838099272(21)544, (01)00884838099272(21)906, (01)00884838099272(21)289, (01)00884838099272(21)548, (01)00884838099272(21)238, (01)00884838099272(21)299, (01)00884838099272(21)284, (01)00884838099272(21)404, (01)00884838099272(21)283, (01)00884838099272(21)401, (01)00884838099272(21)833, (01)00884838099272(21)895, (01)00884838099272(21)233, (01)00884838099272(21)224, (01)00884838099272(21)1087, (01)00884838099272(21)395, (01)00884838099272(21)444, (01)00884838099272(21)710, (01)00884838099272(21)820, (01)00884838099272(21)235, (01)00884838099272(21)846, (01)00884838099272(21)727, (01)00884838099272(21)1026, (01)00884838099272(21)1129, (01)00884838099272(21)777, (01)00884838099272(21)481, (01)00884838099272(21)431, (01)00884838099272(21)696, (01)00884838099272(21)1099, 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(01)00884838099272(21)825, (01)00884838099272(21)877, (01)00884838099272(21)1134, (01)00884838099272(21)1161, (01)00884838099272(21)648, (01)00884838099272(21)831, (01)00884838099272(21)1116, (01)00884838099272(21)1149, (01)00884838099272(21)1104, (01)00884838099272(21)860, (01)00884838099272(21)798, (01)00884838099272(21)603, (01)00884838099272(21)938, (01)00884838099272(21)773, (01)00884838099272(21)939, (01)00884838099272(21)1065, (01)00884838099272(21)716, (01)00884838099272(21)1133, (01)00884838099272(21)672, (01)00884838099272(21)1109, (01)00884838099272(21)1124, (01)00884838099272(21)995, (01)00884838099272(21)813, (01)00884838099272(21)1163, (01)00884838099272(21)580, (01)00884838099272(21)384, (01)00884838099272(21)896, (01)00884838099272(21)636, (01)00884838099272(21)720, (01)00884838099272(21)742, (01)00884838099272(21)832, (01)00884838099272(21)902, (01)00884838099272(21)867, (01)00884838099272(21)872, (01)00884838099272(21)418, (01)00884838099272(21)231, (01)00884838099272(21)1035, (01)00884838099272(21)1055, (01)00884838099272(21)745, (01)00884838099272(21)1033, (01)00884838099272(21)1105, (01)00884838099272(21)637, (01)00884838099272(21)953, (01)00884838099272(21)546, (01)00884838099272(21)844, (01)00884838099272(21)276, (01)00884838099272(21)649, (01)00884838099272(21)855, (01)00884838099272(21)288, (01)00884838099272(21)137, (01)00884838099272(21)68, (01)00884838099272(21)811, (01)00884838099272(21)652. Serial Numbers: 209, 675, 1091, 113, 1145, 1078, 197, 687, 680, 280, 343, 98, 332, 341, 1162, 554, 337, 400, 757, 326, 323, 262, 1017, 379, 786, 462, 573, 458, 987, 880, 141, 693, 510, 882, 1157, 21, 1050, 367, 184, 178, 179, 250, 1139, 1062, 575, 1121, 950, 368, 176, 712, 829, 249, 576, 1046, 708, 738, 1083, 1098, 717, 1126, 665, 764, 386, 977, 721, 1006, 232, 682, 789, 698, 331, 1097, 1094, 378, 808, 718, 195, 412, 715, 1143, 775, 1073, 982, 282, 617, 958, 222, 430, 1067, 810, 1114, 314, 762, 1102, 359, 978, 1060, 920, 1136, 836, 835, 795, 800, 899, 838, 944, 1123, 335, 1039, 203, 731, 725, 701, 967, 501, 992, 119, 732, 974, 919, 605, 686, 230, 523, 327, 477, 1049, 298, 993, 522, 520, 521, 259, 909, 142, 263, 422, 17, 1057, 36, 1103, 164, 485, 1155, 1054, 366, 1140, 1048, 752, 1088, 47, 544, 906, 289, 548, 238, 299, 284, 404, 283, 401, 833, 895, 233, 224, 1087, 395, 444, 710, 820, 235, 846, 727, 1026, 1129, 777, 481, 431, 696, 1099, 438, 552, 630, 941, 429, 854, 888, 596, 957, 645, 739, 736, 1127, 1117, 527, 251, 1000, 965, 553, 1160, 1042, 699, 1064, 574, 741, 740, 1137, 900, 901, 887, 949, 632, 1112, 1156, 737, 907, 825, 877, 1134, 1161, 648, 831, 1116, 1149, 1104, 860, 798, 603, 938, 773, 939, 1065, 716, 1133, 672, 1109, 1124, 995, 813, 1163, 580, 384, 896, 636, 720, 742, 832, 902, 867, 872, 418, 231, 1035, 1055, 745, 1033, 1105, 637, 953, 546, 844, 276, 649, 855, 288, 137, 68, 811, 652.
|
| FEI Number |
3042175844
|
Recalling Firm/
Manufacturer |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Veenpluis 6
Best
Netherlands
|
Manufacturer Reason
for Recall | Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images. |
|---|
FDA Determined
Cause 2 | Equipment maintenance |
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| Action | Philips Medical notified consignees on about 10/06/2026 via certified mailed letter titled "URGENT Medical Device Correction." Consignees were instructed that affected systems may continue to be used in accordance with their Instructions for Use (IFU) and the additional instructions provided, which include: if motorized movements become unavailable, the stand can be manually repositioned using the handgrips and brake controls located on both sides of the stand. For ceiling-mounted systems, manual longitudinal (1), transversal (2), and rotational (3) stand movements remain available. Note: Transversal stand movements (2) are only available for ceiling-mounted systems with the FlexMove option. For floor-mounted systems, only rotational (3) stand movements remain available. The table longitudinal position (4) can be adjusted manually when the table is not tilted.
Additionally, consignees were instructed to ensure the notification letter is distributed to all relevant users, maintained with the device documentation until corrective actions are completed, to post the letter near affected devices for ease of reference, notify customers/organizations if affected systems have been distributed or transferred, and complete and return the response form provided.
Philips will inspect all systems in scope and replace SSDs that are not specified in the Medical Device File. Philips expects to start the implementation of this correction in December 2026. A local Philips representative will contact consignees to schedule a visit for a Field Service Engineer to perform these activities. |
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| Quantity in Commerce | 457 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussal, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, South, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Vietnam, Yemen. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = OWB
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