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Terminated

Cathcor/LX/Desktop, System, X-Ray, Angiographic

FDA Recall Z-1032-03 · Posted 2003-07-19

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeIZI
Date Initiated2002-11-27
Date Terminated2006-10-03
Product Quantity9

Reason for Recall

Incorrect CTR values are found when used with ODBC interface, and may result in misdiagnosis.

Firm Action

A Customer Safety Advisory Letter was sent via registered mail on 10/30/2002.

Root Cause

Other

Distribution Pattern

5 Hospitals/Clinics in the US.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002137CATHCOR DESKTOPSiemens Elema AB · 2000-10-05

Official Source

View FDA Recall →

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

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