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Terminated

Somatom Definition Model AS/AS+, Model number 8098027. Intended use: Computed Tomography X-ray system

FDA Recall Z-1675-2009 · Posted 2009-07-30

Recalling FirmSiemens Medical Solutions USA, Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2009-05-29
Date Terminated2009-09-01
Product Quantity93 units

Reason for Recall

Support mechanism may not engage properly due to improper stowage after opening which may result in internal component damage or potential injury.

Firm Action

The firm has issued a modification of the telescope support arm parking bracket via Update Instruction CT028/09/S. A firm service representative will install the modified support arm parking brackets on the affected systems.

Root Cause

Equipment maintenance

Distribution Pattern

Nationwide Distribution -- including states of AR, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, MA, MD, MN, MO, MT, NC, ND, NE, NH, NY, OH, PA, SC, SD, TN, VA, WA, WI, 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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