Home / Recalls / PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. / Z-0295-2027

Z-0295-2027 Class II Ongoing

Recalled by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Best

FDA device recall Z-0295-2027 was initiated by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. on Oct 6, 2026 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 465 units.

Recall details

Product Type
Devices
Report Date
Nov 4, 2026
Initiation Date
Oct 6, 2026
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
465 units

Product description

Philips Azurion 5 M20. Model Numbers: 722228, 722281.

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.

Distribution pattern

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.

Code information

1. Model Number: 722228. UDI Numbers: (01)00884838099234(21)49, (01)00884838099234(21)159, (01)00884838099234(21)180, (01)00884838099234(21)273, (01)00884838099234(21)132, (01)00884838099234(21)533, (01)00884838099234(21)47, (01)00884838099234(21)522, (01)00884838099234(21)32, (01)00884838099234(21)23, (01)00884838099234(21)25, (01)00884838099234(21)62, (01)00884838099234(21)48, (01)00884838099234(21)153, (01)00884838099234(21)431, (01)00884838099234(21)113, (01)00884838099234(21)529, (01)00884838099234(21)659, (01)00884838099234(21)145, (01)00884838099234(21)567, (01)00884838099234(21)539, (01)00884838099234(21)645, (01)00884838099234(21)308, (01)00884838099234(21)333, (01)00884838099234(21)335, (01)00884838099234(21)570, (01)00884838099234(21)560, (01)00884838099234(21)44, (01)00884838099234(21)569, (01)00884838099234(21)418, (01)00884838099234(21)280, (01)00884838099234(21)616, (01)00884838099234(21)568, (01)00884838099234(21)471, (01)00884838099234(21)428, (01)00884838099234(21)465, 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(01)00884838099234(21)668, (01)00884838099234(21)223, (01)00884838099234(21)312, (01)00884838099234(21)218, (01)00884838099234(21)513, (01)00884838099234(21)442, (01)00884838099234(21)548, (01)00884838099234(21)174, (01)00884838099234(21)486, (01)00884838099234(21)487, (01)00884838099234(21)84, (01)00884838099234(21)346, (01)00884838099234(21)172, (01)00884838099234(21)217, (01)00884838099234(21)575, (01)00884838099234(21)697, (01)00884838099234(21)196, (01)00884838099234(21)676, (01)00884838099234(21)677, (01)00884838099234(21)118, (01)00884838099234(21)415, (01)00884838099234(21)452, (01)00884838099234(21)179, (01)00884838099234(21)331, (01)00884838099234(21)297, (01)00884838099234(21)412, (01)00884838099234(21)427, (01)00884838099234(21)488, (01)00884838099234(21)500, (01)00884838099234(21)588, (01)00884838099234(21)443, (01)00884838099234(21)663, (01)00884838099234(21)747, (01)00884838099234(21)754, (01)00884838099234(21)621, (01)00884838099234(21)766, (01)00884838099234(21)90, 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(01)00884838099234(21)302, (01)00884838099234(21)166, (01)00884838099234(21)432, (01)00884838099234(21)356, (01)00884838099234(21)357, (01)00884838099234(21)305, (01)00884838099234(21)620, (01)00884838099234(21)220, (01)00884838099234(21)325, (01)00884838099234(21)545, (01)00884838099234(21)405, (01)00884838099234(21)514, (01)00884838099234(21)341, (01)00884838099234(21)342, (01)00884838099234(21)184, (01)00884838099234(21)426, (01)00884838099234(21)497, (01)00884838099234(21)183, (01)00884838099234(21)195, (01)00884838099234(21)282, (01)00884838099234(21)490, (01)00884838099234(21)421, (01)00884838099234(21)440, (01)00884838099234(21)446, (01)00884838099234(21)320, (01)00884838099234(21)281, (01)00884838099234(21)480, (01)00884838099234(21)364, (01)00884838099234(21)448, (01)00884838099234(21)283, (01)00884838099234(21)473, (01)00884838099234(21)321, (01)00884838099234(21)476, (01)00884838099234(21)681, (01)00884838099234(21)409, (01)00884838099234(21)535, (01)00884838099234(21)519, (01)00884838099234(21)384, (01)00884838099234(21)489, (01)00884838099234(21)361, (01)00884838099234(21)787, (01)00884838099234(21)303, (01)00884838099234(21)413, (01)00884838099234(21)785, (01)00884838099234(21)765, (01)00884838099234(21)512, (01)00884838099234(21)437, (01)00884838099234(21)656, (01)00884838099234(21)336, (01)00884838099234(21)200, (01)00884838099234(21)504, (01)00884838099234(21)94, (01)00884838099234(21)494, (01)00884838099234(21)667, (01)00884838099234(21)408, (01)00884838099234(21)532, (01)00884838099234(21)698, (01)00884838099234(21)449, (01)00884838099234(21)438, (01)00884838099234(21)453, (01)00884838099234(21)106, (01)00884838099234(21)311, (01)00884838099234(21)459, (01)00884838099234(21)477, (01)00884838099234(21)330, (01)00884838099234(21)167, (01)00884838099234(21)549, (01)00884838099234(21)784, (01)00884838099234(21)390, (01)00884838099234(21)261, (01)00884838099234(21)334, (01)00884838099234(21)337, (01)00884838099234(21)467, (01)00884838099234(21)304, 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Serial Numbers: 49, 159, 180, 273, 132, 533, 47, 522, 32, 23, 25, 62, 48, 153, 431, 113, 529, 659, 145, 567, 539, 645, 308, 333, 335, 570, 560, 44, 569, 418, 280, 616, 568, 471, 428, 465, 102, 176, 103, 178, 109, 16, 234, 566, 571, 463, 647, 317, 562, 552, 680, 724, 561, 517, 203, 773, 260, 107, 100, 108, 640, 99, 101, 318, 602, 75, 78, 531, 574, 370, 464, 580, 496, 668, 223, 312, 218, 513, 442, 548, 174, 486, 487, 84, 346, 172, 217, 575, 697, 196, 676, 677, 118, 415, 452, 179, 331, 297, 412, 427, 488, 500, 588, 443, 663, 747, 754, 621, 766, 90, 739, 498, 743, 707, 738, 755, 708, 284, 742, 725, 565, 745, 201, 457, 458, 690, 46, 171, 34, 229, 332, 306, 610, 646, 429, 56, 601, 257, 608, 763, 590, 591, 628, 197, 366, 345, 627, 302, 166, 432, 356, 357, 305, 620, 220, 325, 545, 405, 514, 341, 342, 184, 426, 497, 183, 195, 282, 490, 421, 440, 446, 320, 281, 480, 364, 448, 283, 473, 321, 476, 681, 409, 535, 519, 384, 489, 361, 787, 303, 413, 785, 765, 512, 437, 656, 336, 200, 504, 94, 494, 667, 408, 532, 698, 449, 438, 453, 106, 311, 459, 477, 330, 167, 549, 784, 390, 261, 334, 337, 467, 304, 212, 340, 515, 173, 219, 160, 634, 82, 732, 133, 733, 208, 165, 378, 685, 164, 228, 701, 401, 161, 147, 723, 691, 730, 146, 170, 295, 290, 316, 207, 686, 119. 2. Model Number: 722281. UDI Numbers: (01)00884838110564(21)379, (01)00884838110564(21)233, (01)00884838110564(21)391, (01)00884838110564(21)334, (01)00884838110564(21)55, (01)00884838110564(21)37, (01)00884838110564(21)21, (01)00884838110564(21)496, (01)00884838110564(21)278, (01)00884838110564(21)467, (01)00884838110564(21)390, (01)00884838110564(21)27, (01)00884838110564(21)366, (01)00884838110564(21)140, (01)00884838110564(21)60, (01)00884838110564(21)487, (01)00884838110564(21)341, (01)00884838110564(21)338, (01)00884838110564(21)108, (01)00884838110564(21)24, (01)00884838110564(21)306, (01)00884838110564(21)328, (01)00884838110564(21)129, (01)00884838110564(21)417, (01)00884838110564(21)457, (01)00884838110564(21)521, (01)00884838110564(21)356, (01)00884838110564(21)428, (01)00884838110564(21)66, (01)00884838110564(21)145, (01)00884838110564(21)401, (01)00884838110564(21)402, (01)00884838110564(21)488, (01)00884838110564(21)444, (01)00884838110564(21)431, (01)00884838110564(21)115, 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(01)00884838110564(21)87, (01)00884838110564(21)49, (01)00884838110564(21)166, (01)00884838110564(21)72, (01)00884838110564(21)531, (01)00884838110564(21)47, (01)00884838110564(21)454, (01)00884838110564(21)242, (01)00884838110564(21)480, (01)00884838110564(21)234, (01)00884838110564(21)197, (01)00884838110564(21)206, (01)00884838110564(21)518, (01)00884838110564(21)519, (01)00884838110564(21)58, (01)00884838110564(21)263, (01)00884838110564(21)193, (01)00884838110564(21)280, (01)00884838110564(21)452, (01)00884838110564(21)118, (01)00884838110564(21)137, (01)00884838110564(21)303, (01)00884838110564(21)439, (01)00884838110564(21)302, (01)00884838110564(21)195, (01)00884838110564(21)103, (01)00884838110564(21)471, (01)00884838110564(21)443, (01)00884838110564(21)196, (01)00884838110564(21)408, (01)00884838110564(21)579, (01)00884838110564(21)29, (01)00884838110564(21)502, (01)00884838110564(21)512, (01)00884838110564(21)163, (01)00884838110564(21)437, (01)00884838110564(21)111, (01)00884838110564(21)368, (01)00884838110564(21)479, (01)00884838110564(21)42, (01)00884838110564(21)412, (01)00884838110564(21)411, (01)00884838110564(21)449, (01)00884838110564(21)184, (01)00884838110564(21)185, (01)00884838110564(21)30, (01)00884838110564(21)31, (01)00884838110564(21)25, (01)00884838110564(21)483, (01)00884838110564(21)106, (01)00884838110564(21)142, (01)00884838110564(21)128, (01)00884838110564(21)504, (01)00884838110564(21)506, (01)00884838110564(21)478, (01)00884838110564(21)505, (01)00884838110564(21)473, (01)00884838110564(21)507, (01)00884838110564(21)16, (01)00884838110564(21)475, (01)00884838110564(21)257, (01)00884838110564(21)262, (01)00884838110564(21)165, (01)00884838110564(21)248, (01)00884838110564(21)288. Serial Numbers: 379, 233, 391, 334, 55, 37, 21, 496, 278, 467, 390, 27, 366, 140, 60, 487, 341, 338, 108, 24, 306, 328, 129, 417, 457, 521, 356, 428, 66, 145, 401, 402, 488, 444, 431, 115, 446, 17, 517, 12, 65, 125, 339, 351, 337, 364, 210, 188, 203, 476, 419, 542, 295, 236, 307, 350, 304, 342, 410, 38, 228, 19, 105, 344, 80, 225, 186, 352, 426, 117, 500, 396, 270, 11, 219, 371, 157, 290, 102, 389, 442, 23, 9, 458, 168, 204, 432, 466, 463, 447, 310, 35, 155, 485, 468, 418, 76, 430, 126, 450, 365, 207, 377, 85, 406, 276, 327, 226, 156, 170, 407, 101, 229, 434, 88, 291, 89, 68, 221, 33, 367, 289, 83, 10, 363, 39, 326, 331, 57, 178, 323, 13, 251, 477, 325, 82, 222, 121, 134, 510, 96, 448, 75, 91, 374, 414, 501, 87, 49, 166, 72, 531, 47, 454, 242, 480, 234, 197, 206, 518, 519, 58, 263, 193, 280, 452, 118, 137, 303, 439, 302, 195, 103, 471, 443, 196, 408, 579, 29, 502, 512, 163, 437, 111, 368, 479, 42, 412, 411, 449, 184, 185, 30, 31, 25, 483, 106, 142, 128, 504, 506, 478, 505, 473, 507, 16, 475, 257, 262, 165, 248, 288.

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-0295-2027
openFDA file date
Nov 10, 2026
Loaded by RegDataLab
Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

  • Z-0293-2027 Class II — Philips Azurion 3 M15. Model Number: 722064, 722222, 722280. (Oct 6, 2026)
  • Z-0292-2027 Class II — Philips Azurion 3 M12. Model Numbers: 722063, 722221. (Oct 6, 2026)
  • Z-0296-2027 Class II — Philips Azurion 7 B12. Model Numbers: 722067, 722225. (Oct 6, 2026)
  • Z-0298-2027 Class II — Philips Azurion 7 M12. Model Numbers: 722078, 722223. (Oct 6, 2026)
  • Z-0300-2027 Class II — Philips Azurion S. Model Number: 722285. (Oct 6, 2026)
  • Z-0299-2027 Class II — Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282. (Oct 6, 2026)
  • Z-0297-2027 Class II — Philips Azurion 7 B20. Model Numbers: 722068, 722226. (Oct 6, 2026)
  • Z-0294-2027 Class II — Philips Azurion 5 M12. Model Number: 722227. (Oct 6, 2026)
  • Z-2932-2026 Class II — Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234… (Jul 16, 2026)
  • Z-2931-2026 Class II — Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078… (Jul 16, 2026)

FDA data resources

Source: openFDA record for Z-0295-2027. Report a data issue: hello@regdatalab.com.