Class 1 Device Recall Allura Xper FD series and Allura Xper OR Table series

• Date Initiated by Firm: January 13, 2025
• Date Posted: February 20, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1143-2025
• Recall Event ID: 96132
• 510(K)Number: K033737 K130842 K162859
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
• Code Information: 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
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: Possibility of the patient falling from the table related to the mattress used on the patient table.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB; 510(K)s with Product Code = OWB