Siemens Medical Solutions USA, Inc Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial numbers: 14002-14004, 14006-14012, 14014, 14018, 14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049, 14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071, 14074-14075, 14080-14081, 14084-14088, and 14092
Products Sold
Serial numbers: 14002-14004, 14006-14012, 14014, 14018, 14021, 14025, 14029, 14033, 14041-14042, 14044-14045, 14049, 14051, 14055, 14058, 14060-14065, 14064-14065, 14068, 14071, 14074-14075, 14080-14081, 14084-14088, and 14092
Siemens Medical Solutions USA, Inc is recalling Axiom Artis BA or BC Biplane System, Angiographic x-ray system, Model number 59 04 649 due to Opacification Function of device may incorrectly merge images. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Opacification Function of device may incorrectly merge images
Recommended Action
Per FDA guidance
The recalling firm has issued a Customer Safety Advisory letter with Update Instructions AX067/04/S to the affected customers via certified mail on 8/12/04. The recalling firm is preparing a software update to correct the problem.
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