—#33793

Product

AXIOM Sensis Report Workstation. Programmable diagnostic computer. Model number 6627637

FDA product code: DQK — Computer, Diagnostic, Programmable
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K020440
Affected lot / code info: Serial Numbers 1002, 1034, 1100-1253, 1300-1504

Why it was recalled

Software issue. Allows for users to enter date in Pre-Cath Holding Area prior to registering the patient in the Cath Lab.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: The product was shipped to 43 medical facilities nationwide and one government account in KY.

Timeline

Recall initiated: 2004-05-17
Posted by FDA: 2004-09-14
Terminated: 2005-04-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #33793. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.