RecallRadar

FDA Device recall Z-2529-2025

Artis Pheno

On 2025-09-17 the FDA classified a Class II recall of Artis Pheno by Siemens Medical Solutions Usa, citing limited system movements after startup .

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2529-2025
ClassificationClass II
Statusongoing
Initiated2025-08-12
Published2025-09-17
Last updated2026-09-13 11:57 UTC
CompanySiemens Medical Solutions Usa
DistributionUS

Product

Artis Pheno. Image-Intensified Flouroscopic X-Ray System.

Reason

Limited system movements after startup .

Identifiers

code_info
Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164…Model No. 10849000; UDI: 04056869046877; Serial No. 164184, 164183, 164071, 164072, 164027, 164026, 164094, 164019, 164161, 164152, 164069, 164086, 164084, 164158, 164188, 164105, 164080, 164011, 164100, 164097,

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-2529-2025%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.