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Azurion recallZ-1156-2025 · Philips Medical Systems Nederland B.V. · initiated Jan 13, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips Medical Systems Nederland B.V. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Possibility of the patient falling from the table related to the mattress used on the patient table.

FDA root cause category: Under Investigation by firm

What the company is doing

On January 14, 2025 URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. 4. Actions that should be taken by the customer / user in order to prevent risks for patients or users " Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. " Follow the additional instructions on the use of the mattress included in Appendix B. These instructions include information for the transfer of the patient and the correct use and positioning of the mattress. The information of this Appendix is being included in an Addendum to the Instructions for Use. Additionally, Philips is creating a Quick Reference Card. The Addendum and the Quick Reference Card will be available as from end of March 2025. Please refer to Appendix C on how to download the Addendum to the Instructions for Use and the Quick Reference Card. " In case that the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through the email account: [email protected] " Please complete and return the Response form attached to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction letter and understanding of the issue and required actions to be taken. " Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative (1- 800-722-9377). 5. Actions planned by Philips Image Guided Therapy Systems to correct the problem Philips is informing customers of this issue through this Urgent Medical Device Correction. Additionally, Philips is releasing an Addendum to the Instructions for Use and a Quick Reference Card that will be available for customers at the end of March 2025. This Urgent Medical Device Correction letter has been reported to the appropriate Regulatory Agencies.

Recall details

Recall number
Z-1156-2025
Status
Open, Classified
Initiated by the company
Jan 13, 2025
Posted by the FDA
Feb 20, 2025
Recalling firm
Philips Medical Systems Nederland B.V.
Quantity
632 units (77 US, 555 OUS)
Product code
OWB
FDA submissions
K172822, K200917
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.

Product description

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

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.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 96132).

Sources and updates

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