CLASS I ONGOING Device recall · Reported 26 Feb 2025 · FDA Enforcement Report
Azurion 5 M20 recalled by Philips Medical Systems
Philips Medical Systems Nederland B.v is recalling Azurion 5 M20, distributed nationwide in the US. The recall was initiated on 13 Jan 2025 and the FDA has classified it as Class I.
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-1156-2025
- FDA event ID
- 96132
- Recalling firm
- Philips Medical Systems Nederland B.v, Best, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 13 Jan 2025
- FDA classified
- 20 Feb 2025
- Reported
- 26 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Jan 2025 | Recall initiated by company | |
| 20 Feb 2025 | Classified by FDA | +38 days |
| 26 Feb 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Possibility of the patient falling from the table related to the mattress used on the patient table.
Product as listed by the FDA
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Where it was distributed
Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.
Questions about this recall
Is Azurion 5 M20 recalled?
Yes. Philips Medical Systems Nederland B.v recalled Azurion 5 M20 on 13 Jan 2025. The recall is Class I and its status is Ongoing. Recall number Z-1156-2025.
Why was it recalled?
Possibility of the patient falling from the table related to the mattress used on the patient table.
Which lots are affected?
Catalog numbers: (1) 722228, (2) 722232(OUS ONLY), (3) 722281 (OUS ONLY); UDI-DI: (1) 00884838099234, (2) 00884838116757, (3) no UDI; Serial Numbers: (1) 522, 187, 328, 113, 205, 204, 273, 180, 61, 523, 132, 149, 48, 79, 80, 37, 481, 17, 150, 32, 159, 23, 25, 29, 431, 127, 38, 87, 47, 24, 373, 91, 399, 10, 36, 6, 49, 211, 189, 231, 123, 124, 185, 186, 198, 213, 122, 64, 20, 157, 26, 110, 403, 529, 181, 177, 524, 573, 62, 128, 153, 45, 502, 215, 92, 67, 18, 76, 504, 395, 125, 391, 178, 229, 106, 56, 12, 408, 89, 194, 60, 193, 377, 190, 383, 464, 462, 138, 94, 309, 310, 93, 114, 145, 365, 311, 611, 629, 440, 368, 590, 591, 360, 421, 195, 501, 292, 364, 490, 352, 297, 386, 525, 448, 182, 473, 404, 503, 376, 534, 486, 487, 606, 196, 280, 166, 340, 438, 220, 212, 535, 362, 555, 607, 608, 302, 489, 424, 425, 183, 402, 405, 258, 320, 384, 434, 314, 306, 325, 497, 305, 307, 338, 432, 581, 283, 412, 443, 313, 626, 446, 426, 282, 387, 327, 350, 542, 439, 500, 321, 329, 303, 291, 620, 472, 476, 433, 493, 281, 480, 203, 442, 513, 454, 345, 304, 288, 341, 342, 430, 257, 409, 543, 366, 514, 556, 418, 197, 324, 308, 361, 217, 557, 98, 260, 33, 261, 179, 174, 548, 346, 214, 1, 3, 536, 143, 46, 429, 70, 21, 22, 7, 13, 191, 259, 343, 218, 83, 158, 156, 437, 467, 349, 374, 117, 104, 385, 369, 199, 57, 293, 518, 508, 43, 444, 5, 406, 546, 474, 498, 417, 407, 510, 284, 90, 414, 201, 130, 73, 469, 99, 100, 101, 107, 108, 449, 427, 488, 66, 115, 116, 192, 416, 144, 28, 11, 30, 68, 233, 27, 59, 298, 55, 419, 119, 34, 601, 344, 200, 118, 415, 436, 317, 515, 588, 506, 516, 234, 31, 88, 230, 318, 390, 223, 312, 319, 286, 471, 370, 482, 475, 102, 103, 176, 389, 14, 16, 109, 575, 477, 494, 167, 353, 9, 95, 294, 597, 598, 228, 466, 175, 97, 163, 316, 160, 492, 162, 290, 170, 164, 168, 285, 479, 136, 65, 478, 207, 81, 401, 378, 121, 540, 208, 289, 133, 295, 147, 82, 146, 161, 141, 165, 139, 140, 135, 134, 71, 63, 74, 39, 465, 552, 554, 463, 435, 413, 85, 172, 52, 35, 53, 216, 154, 339, 202, 483, 232, 333, 335, 171, 566, 568, 571, 453, 561, 560, 334, 331, 337, 330, 539, 569, 332, 459, 452, 75, 78, 531, 574, 602, 336, 579, 173, 496, 580, 86, 44, 512, 184, 299, 84, 428, 517 ****Serial Numbers Added 5/2/2025**** 533, 537, 538, 600, 615, 617, 618, 619, 642, 219, 348, 392, 393, 394; (2) OUS ONLY 1 ****Serial Numbers Added 5/2/2025**** 2, 3, 4, 8, 11, 16, 20, 28, 29, 30, 37, 57, 58; (3) OUS ONLY 90, 48, 50, 114, 62, 33, 21, 127, 36, 95, 87, 86, 79, 29, 140, 110, 32, 60, 76, 111, 9, 70, 55, 121, 75, 14, 66, 22, 146, 23, 44, 45, 58, 42, 137, 13, 122, 52, 61, 109, 41, 34, 103, 16, 132, 117, 17, 102, 72, 158, 99, 35, 160, 30, 31, 37, 135, 94, 57, 138, 10, 26, 59, 80, 63, 74, 27, 28, 54, 88, 24, 11, 20, 101, 89, 91, 157, 19, 12, 96, 64, 69 ****Serial Numbers Added 5/2/2025**** 15, 18, 25, 38, 39, 40, 43, 47, 65, 68, 71, 81, 84, 93, 98, 105, 108, 115, 118, 120, 124, 126, 136, 142, 144, 149, 151, 153, 159, 163, 168, 169, 173, 174, 176, 179, 180, 181, 182, 186, 187, 190, 191, 192, 193, 196, 197, 198, 207, 211, 213, 224, 225, 227, 231, 236, 242.
Where was it sold?
Worldiwde distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of, Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of, Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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