RecallRadar

FDA Device recall Z-1145-2025

Allura Xper FD20 Biplane

On 2025-02-26 the FDA classified a Class I recall of Allura Xper FD20 Biplane 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

AgencyFDA Device
Recall numberZ-1145-2025
ClassificationClass I
Statusongoing
Initiated2025-01-13
Published2025-02-26
Last updated2026-09-13 11:57 UTC
CompanyPhilips Medical Systems Nederland B V
DistributionUS

Product

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

Reason

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

Identifiers

code_info
Catalog numbers: (1) 722008, (2) 722013; UDI-DI: (1) No UDI, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325…Catalog numbers: (1) 722008, (2) 722013; UDI-DI: (1) No UDI, (2) 00884838059061; Serial Numbers: (1) 491, 489, 360, 325, 142, 312, 319, 516, 244, 453, 306, 378, 124, 18270, 524, 463, 197, 264, 294, 246, 320, 357, 212, 459, 472, 483, 465, 419, 38, 454, 441, 460, 369, 407, 231, 437, 105, 420, 1178, 270, 442, 521, 372, 254, 365, 390, 413, 379, 18, 239, 288, 424, 279, 481, 304, 267, 361, 415, 245, 445, 296, 487, 349, 456, 470, 386, 37, 205, 371, 416, 339, 513, 355, 337, 476, 121, 169, 327, 289, 518, 242, 93, 542, 122, 376, 543, 87, 391, 499, 253, 259, 393, 447, 495, 250, 110, 273, 31, 553, 433, 63, 398, 546, 213, 356, 408, 404, 448, 305, 475, 6001385, 425, 435, 450, 480, 370, 167, 323, 247, 525, 455, 394, 160, 350, 406, 274, 388, 283, 359, 8, 346, 335, 458, 410, 367, 266, 268, 482, 272, 385, 290, 468, 446, 46, 334 ****Serial Numbers Added 5/2/2025**** 378, 379, 516, 242, 274, 335, 367, 371, 393; (2) 505, 217, 313, 113, 34, 153, 410, 360, 290, 74, 83, 580, 160, 404, 126, 244, 106,

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-1145-2025%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.