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Terminated

Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +

FDA Recall Z-0322-03 · Posted 2002-12-05

Recalling FirmSiemens Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2002-07-10
Date Terminated2003-03-24
Product Quantity250

Reason for Recall

Head holder cannot be properly secured on the table top.

Firm Action

Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.

Root Cause

Other

Distribution Pattern

The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.

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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