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Terminated

Somatom Definition AS, Model number 8098027. Computed tomography x-ray system

FDA Recall Z-0929-2009 · Posted 2009-01-23

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2008-12-09
Date Terminated2009-09-23
Product Quantity42 units

Reason for Recall

possible improper installation of tilt transport lock/tilt limiter

Firm Action

The recalling firm received a letter dated 11/25/08 from the manufacturer informing them of the problem. As a result, the recalling firm has issued Update Instruction CT065/08/S to have the transport lock/tilt limiter on the device visually inspected. The tilted scan modes have been disabled until the modified lock/tilt limiter has been installed.

Root Cause

Labeling Change Control

Distribution Pattern

Nationwide Distribution --- including states of AZ, CA, CO, FL, IL, KS, KY, MA, MI, MN, MO, NE, NY, OH, PA, SC, VA, and WY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081022SOMATOM DEFINITION, MODEL AS/AS+Siemens Medical Solutions USA, Inc. · 2008-06-02

Official Source

View FDA Recall →

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

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