RecallRadar

FDA Device recall Z-1148-2025

Allura Xper FD20/10

On 2025-02-26 the FDA classified a Class I recall of Allura Xper FD20/10 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

AgencyFDA Device
Recall numberZ-1148-2025
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 FD20/10; Catalog numbers: 722029

Reason

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

Identifiers

code_info
Catalog number: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129…Catalog number: 722029; UDI-DI: 00884838054219; Serial Numbers: 71, 91, 7, 94, 62, 88, 36, 97, 21, 100, 30, 63, 60, 129, 84, 95, 126, 110, 56, 55, 57, 31, 119, 87, 93, 24, 32, 39, 34, 14, 122, 127, 45, 48, 37, 23, 44, 40, 66, 38, 98, 75, 35, 89, 82, 61, 53, 25, 58, 33, 85, 27, 46, 19, 29, 20, 92, 52, 104, 70, 65, 109, 78, 96, 26, 59, 118, 108, 49, 50, 51, 128, 107, 114, 124, 103, 106, 81, 80, 47, 123, 116, 101, 79, 120, 43, 102.

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-1148-2025%22

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