PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

Recall number

Z-1143-2025

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Product

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.

Status

Open, Classified

Initiated

2025-01-13

Posted

2025-02-20

Terminated

not on file

Reason

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

Root cause

Under Investigation by firm

Action

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: IGT_Recalls@philips.com " 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.

Quantity

590 units (141 US, 449 OUS)

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.

Lot, serial or model codes

Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial Numbers: (1) 361, 212, 321, 435, 285, 384, 388, 340, 343, 399, 392, 565, 355, 367, 308, 348, 271, 530, 520, 323, 510, 49, 329, 365, 269, 270, 523, 490, 357, 346, 258, 298, 316, 485, 8095, 261, 2189, 352, 474, 497, 251, 63, 456, 360, 305, 419, 405, 489, 306, 307, 429, 447, 345, 342, 272, 531, 440, 441, 416, 116, 121, 136, 58, 561, 351, 52, CV.502, 478, 8, 55, 560, 341, 403, 25, 54, 354, 385, 26, 234, 287, 459, 469, 300, 494, 72, 76, 564, 754, 125, 519, 457, 373, 430, 499, 332, 508, 374, 85, 463, 464, 428, 500, 276, 359, 487, 538, 415, 328, 397, 366, 389, 378, 379, 371, 81, 511, 473, 209, 369, 543, 394, 507, 533, 482, 495, 333, 237, 339, 338, 467, 528, 53, 401, 325, 491 ****Serial Numbers Added 5/2/2025**** 63, 308, 8095, 8, 81, 116, 121, 136, 300, 325, 345. (2) 157, 83, 268, 308, 380, 95, 107, 34, 59, 23, 319, 49, 170, 137, 173, 101, 84, 155, 133, 234, 345, 124, 332, 102, 270, 177, 132, 325, 15, 76, 79, 17, 237, 255, 50, 171, 362, 168, 22, 275, 344, 324, 163, 375, 103, 82, 154, 215, 40, 328, 69, 374, 286, 81, 272, 293, 294, 224, 175, 117, 334, 338, 6, 146, 145, 355, 231, 323, 164, 151, 184, 266, 21, 80, 202, 165, 179, 367, 372, 203, 214, 369, 340, 18, 301, 302, 303, 304, 305, 306, 307, 318, 98, 211, 158, 271, 204, 246, 206, 321, 78, 295, 104, 217, 257, 265, 261, 253, 94, 225, 125, 38, 39, 176, 290, 291, 282, 216, 333, 329, 178, 127, 249, 230, 198, 244, 292, 180, 183, 314, 337, 201, 341, 376, 377, 378, 56, 259, 181, 317, 347, 287, 86, 300, 88, 309, 99, 233, 31, 156, 71, 222, 77, 188, 223, 238, 153, 51, 129, 68, 278, 118, 119, 186, 32, 108, 89, 258, 263, 41, 55, 310, 371, 66, 274, 139, 141, 227, 243, 296, 191, 220, 242, 166, 161, 273, 190, 189, 260, 280, 74, 75, 251, 228, 100, 199, 194, 91, 213, 212, 12, 115, 152, 111, 116, 113, 112, 114, 43, 277, 313, 26, 29 ****Serial Numbers Added 5/2/2025**** 87, 124, 172, 237, 31, 36, 51, 78, 113, 151, 161, 175, 179, 181, 191, 225, 243, 291, 296, 369, 371; (3) 203, 335, 123, 133, 134, 284, 280, 183, 106, 169, 107, 234, 42, 179, 101, 265, 306, 307, 209, 267, 153, 40, 332, 156, 112, 305, 1, 104, 231, 263, 342, 71, 255, 351, 175, 298, 120, 116, 174, 240, 241, 29, 50, 288, 56, 152, 43, 49, 202, 178, 266, 127, 319, 39, 164, 160, 27, 64, 78, 98, 245, 221, 352, 99, 55, 6, 86, 360, 7, 145, 214, 102, 204, 44, 210, 254, 84, 228, 297, 268, 77, 114, 115, 142, 30, 79, 38, 85, 189, 181, 321, 343, 144, 177, 165, 225, 211, 201, 3, 246, 291, 217, 215, 73, 315, 68, 87, 304, 51, 308, 289, 355, 21, 23, 24, 90, 171, 45, 128, 34, 122, 220, 33, 137, 287, 163, 67, 88, 232, 150, 208, 96, 310, 143, 155, 20, 166, 198, 242, 243, 269, 239, 147, 139, 180, 91, 136, 191, 197, 118, 193, 59, 312, 309, 311, 69, 296, 119, 276, 278, 250, 65, 168, 206, 158, 218, 66, 329, 75, 19, 141, 62, 330, 219, 138, 121, 264, 227, 286, 18, 31, 272, 235, 131, 195, 28, 326, 192, 207, 199, 125, 233, 148, 149, 58, 271, 212, 184, 328, 362, 5, 46, 47, 236, 135, 275, 159, 316, 277, 249, 223, 270, 322, 100, 103, 110, 57, 63, 244, 274, 256, 273, 61, 348, 349, 350, 36, 151, 300, 299, 167, 247, 282, 60, 259, 81, 126, 130, 70, 188, 347, 213, 339, 358, 94, 154, 172, 35, 346, 294, 97, 196, 76, 95, 357, 345, 361, 323, 324, 292, 293, 187, 337, 334, 338, 238, 356, 170, 146, 53, 162, 48, 205, 182, 82, 260, 261, 117, 80, 113, 186, 132 ****Serial Numbers Added 5/2/2025**** 179, 231, 63, 77, 97, 98;

510(k) numbers

["K130842","K162859","K033737"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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