Reported Feb 26, 2025 · Ongoing
Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
Philips Medical Systems Nederland B.v.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. · Veenpluis 4-6 · Best, N/A · N/A
Is this the product you have?
- Allura Xper FD10/10
- Catalog numbers
(1) 722005(2) 722011(3) 722027
- Lot codes and dates
- 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
- Catalog numbers
- Amount recalled
- 590 units (141 US, 449 OUS)
This recall covers 20 products
The agency filed one notice per product. You are reading one of them; the other 19 are below.
7 more are in the archive.
Where it was sold
- Nationwide
- GA
Why it was recalled
Stop using this product now
Possibility of the patient falling from the table related to the mattress used on the patient table.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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