CLASS II ONGOING Device recall · Reported 4 Nov 2026 · FDA Enforcement Report
Philips Azurion 5 M20 recalled by Philips Medical Systems Nederl
Philips Medical Systems Nederl is recalling Philips Azurion 5 M20, distributed nationwide in the US. The recall was initiated on 6 Oct 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0295-2027
- FDA event ID
- 99939
- Recalling firm
- Philips Medical Systems Nederl, Best
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2026
- FDA classified
- 27 Oct 2026
- Reported
- 4 Nov 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 6 Oct 2026 | Recall initiated by company | |
| 27 Oct 2026 | Classified by FDA | +21 days |
| 4 Nov 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Philips Azurion 5 M20. Model Numbers: 722228, 722281.
Where it was distributed
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.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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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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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 10 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 99939This product is part of a recall event; the main page for the event is Philips Azurion 5 M12 recalled by Philips Medical Systems Nederl.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Philips Azurion 5 M12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion 7 B20 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion 7 M12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion 3 M12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion 7 M20 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion 7 B12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide | |
| CLASS II | Philips Azurion 3 M15 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
More recalls from Philips Medical Systems Nederl
All 209| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Azurion 3 M15 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Azurion 7 B12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Azurion 7 M20 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Azurion 3 M12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Azurion 7 M12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
Other Other Medical Devices recalls
All 13,968| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Philips Azurion 3 M15 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Orthoscan Versa Accessory Cart recalled by Ziehm-orthoscan | Ziehm-orthoscan | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Azurion 7 B12 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Philips Azurion 7 M20 recalled by Philips Medical Systems Nederl | Philips Medical Systems Nederl | Other | Nationwide |
| Device | CLASS II | Carevo, Height-adjustable shower trolley recalled | Arjohuntleigh Polska Sp. z.o.o | Other | Nationwide |