—#74666

Product

Somatom Sensation 64 X-Ray System, Model number 8377520. This is a computed tomography x-ray system which is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K040665
Affected lot / code info: Serial numbers 57084, 57193, 57213, 57261, 57262, 57270, 57272, 57285, and 57298

Why it was recalled

software error - does not allow protocol to properly synchronize with ECG triggers

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued a Customer Safety Advisory Notice dated 9/3/08 to affected customers via Update Instructions CT045/08/S. This letter informs customers of the potential issued and provides instruction to avoid its occurrence. For additional information, contact Siemens Medical Solutions USA, Inc. at 1-610-448-4500.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2008-09-03
Posted by FDA: 2009-01-05
Terminated: 2009-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74666. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.