FDA Device recall Z-1662-2026

ALLURA Xper FD10/10

FDA Device
Class II
ongoing
Published 2026-04-08

On 2026-04-08 the FDA classified a Class II recall of ALLURA Xper FD10/10 by Philips Medical Systems Nederland B V, citing philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1662-2026
Classification	Class II
Status	ongoing
Initiated	2026-03-03
Published	2026-04-08
Last updated	2026-09-13 11:58 UTC
Company	Philips Medical Systems Nederland B V
Distribution	US

Product

ALLURA Xper FD10/10; System Code: (1) 722005, (2)722011, (3)722027;

Reason

Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.

Identifiers

code_info	(1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169,… (1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169, 305, 565, 419, 269, 258, 346, 474, 497, 530, 261, 523, 384, 388, 271, 233, 367, 270, 427, 343, 399, 360, 212, 251, 112, 520, 70, 392, 128, 357, 485, 405, 306, 307, 467, 234, 287, 333, 533, 209, 369, 543, 332, 328, 366, 389, 538, 394, 378, 379, 237, 165, 238, 2724, 415, 482, 397, 53, 385, 52, 531, 58, 499, 229, 374, 25, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 511, 428, 500, 463, 464, 14, 459, 416, 359, 487, 74, 457, 564, 469, 72, 125, 494, 519, 373, 76; (2) System Code: 722011; UDI: 00884838059047; System Serial Number: 49, 137, 375, 332, 102, 103, 95, 107, 380, 132, 171, 157, 270, 362, 76, 79, 22, 234, 308, 34, 324, 177, 84, 82, 319, 17, 133, 168, 345, 344, 83, 59, 15, 170, 163, 101, 255, 173, 325, 87, 155, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 186, 300, 213, 372, 41, 55, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199,

code_info

(1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169,…

(1) System Code: 722005; UDI: N/A; System Serial Number: 321, 285, 490, 51, 298, 329, 49, 361, 323, 355, 456, 316, 169, 305, 565, 419, 269, 258, 346, 474, 497, 530, 261, 523, 384, 388, 271, 233, 367, 270, 427, 343, 399, 360, 212, 251, 112, 520, 70, 392, 128, 357, 485, 405, 306, 307, 467, 234, 287, 333, 533, 209, 369, 543, 332, 328, 366, 389, 538, 394, 378, 379, 237, 165, 238, 2724, 415, 482, 397, 53, 385, 52, 531, 58, 499, 229, 374, 25, 440, 441, 54, 403, 55, 342, 272, 80, 351, 371, 85, 75, 276, 26, 511, 428, 500, 463, 464, 14, 459, 416, 359, 487, 74, 457, 564, 469, 72, 125, 494, 519, 373, 76; (2) System Code: 722011; UDI: 00884838059047; System Serial Number: 49, 137, 375, 332, 102, 103, 95, 107, 380, 132, 171, 157, 270, 362, 76, 79, 22, 234, 308, 34, 324, 177, 84, 82, 319, 17, 133, 168, 345, 344, 83, 59, 15, 170, 163, 101, 255, 173, 325, 87, 155, 40, 154, 215, 273, 222, 203, 214, 220, 242, 166, 71, 156, 36, 186, 300, 213, 372, 41, 55, 100, 190, 278, 258, 299, 260, 280, 32, 89, 199,

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1662-2026%22

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