Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301
FDA Recall Z-2338-2015 · 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.