Recalls / —

—#35340

Product

LEONARDO MM-WS, Computed Tomography X-Ray, Model Number 71 29 534

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K010938

Affected lot / code info

Serial Numbers: 6026, 6037, 6047, 6106, 6114, 6115, 6116, and 20014

Why it was recalled

Calcium Scoring feature on this devices is not closing properly after patient's exams.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

The product was shipped to medical facilities nationwide and government account in IL.

Timeline

Recall initiated

2004-09-28

Posted by FDA

2004-11-03

Terminated

2008-09-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #35340. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.