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Terminated

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

FDA Recall Z-1446-04 · Posted 2004-09-14

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeDQK
Date Initiated2004-05-17
Date Terminated2005-04-11
Product Quantity234 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K020440NEWCORSiemens Medical Systems, Inc. · 2002-12-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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