Siemens Medical Solutions USA, Inc Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: Angiography system for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
Products Sold
Serial Numbers 164231, 164234, 164240, 164241, 164242, 164244
Siemens Medical Solutions USA, Inc is recalling Siemens ARTIS pheno, Model # 10849000. Interventional Fluoroscopic X-Ray System - Product Usage: An due to The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The potential exists for system movement to be permanently blocked by an activation of the collision sensor integrated in the cover of the collimator even when no collision has occurred.
Recommended Action
Per FDA guidance
Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notice to all affected customers via AX070/19/S on 12/20/2019.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026