Siemens Medical Solutions USA, Inc AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Serial Numbers 1002, 1034, 1100-1253, 1300-1504
Products Sold
Serial Numbers 1002, 1034, 1100-1253, 1300-1504
Siemens Medical Solutions USA, Inc is recalling AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637 due to Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.
Recommended Action
Per FDA guidance
The recalling firm issued a Customer Safety Advisory to their customers via certified mail on 5/17/04 to inform them of the problem. The advisory provides Update Instructions AX031/04/S to prevent this problem from occurring until the software upgrade is installed 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