—#138809

Product

Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K123737
Affected lot / code info: SERIAL NUMBERS: 1041, 1042

Why it was recalled

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

Root cause (FDA determination)

Packaging change control

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA Inc.
Address: 810 Innovation Dr, Knoxville, Tennessee 37932-2562

Distribution

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

Timeline

Recall initiated: 2015-07-14
Posted by FDA: 2015-08-05
Terminated: 2016-03-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #138809. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.