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Terminated

SOMATOM CT System Sensation 10, Computed Tomography X-Ray System, Model Number 75 43 015

FDA Recall Z-0162-05 · Posted 2004-11-03

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2004-09-28
Date Terminated2008-09-04
Product Quantity21 units

Reason for Recall

Calcium Scoring feature on this devices is not closing properly after patient's exams.

Firm Action

The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.

Root Cause

Other

Distribution Pattern

The product was shipped to medical facilities nationwide and government account in IL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013522SOMATOM P30 CT SYSTEMSSiemens Medical Systems, Inc. · 2001-11-07

Official Source

View FDA Recall →

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

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