Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Summary
The FDA issued a Class I for Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (O by PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.. Reason: Possibility of the patient falling from the table related to the mattress used on the patient table..
Details
Source
Device Recall
External ID
Z-1156-2025
Action Date
2025-02-26
Status
Ongoing
Category
device
Product Description
Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
Lot/Code Info: 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.
Quantity Affected: 632 units (77 US, 555 OUS)
Reason for Recall
Possibility of the patient falling from the table related to the mattress used on the patient table.
Distribution
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-01-13
Company
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 167 device recalls issued in the same week, part of 413 device-related FDA actions this month.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. have FDA actions?
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. has 236 FDA actions in our database, including 203 recalls and 33 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1156-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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