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Terminated

Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290

FDA Recall Z-2336-2015 · Posted 2015-08-05

Recalling FirmSiemens Medical Solutions USA Inc.
Recall StatusTerminated
Product CodeKPS
Date Initiated2015-07-14
Date Terminated2016-03-03
Product Quantity1 unit

Reason for Recall

Emission computed tomography systems and computed tomography xray systems with optional ceiling mounts may be missing a locking ring.

Firm Action

The firm initiated their recall on 07/14/2015 by telephone to the sole US consignee. The update is scheduled for 07/15/2015.

Root Cause

Packaging change control

Distribution Pattern

Distributed in the state of Texas and the countries of Germany, France, Russia, Denmark, and Switzerland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123737BIOGRAPH MCT FAMILYSiemens Medical Solutions USA, Inc. · 2013-01-29

Official Source

View FDA Recall →

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

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