FDA Device recall Z-1143-2025

Allura Xper FD10/10

FDA Device
Class I
ongoing
Published 2025-02-26

On 2025-02-26 the FDA classified a Class I recall of Allura Xper FD10/10 by Philips Medical Systems Nederland B V, citing possibility of the patient falling from the table related to the mattress used on the patient table.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1143-2025
Classification	Class I
Status	ongoing
Initiated	2025-01-13
Published	2025-02-26
Last updated	2026-09-13 11:57 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

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

Reason

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

Identifiers

code_info	Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial… 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

code_info

Catalog numbers: (1) 722005, (2) 722011, (3) 722027; UDI-DI: (1) No UDI, (2) 00884838059047, (3) 00884838054196; Serial…

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.