Recalls / —

—#139933

Product

SOMATOM Force; computed tomography x-ray system. Intended to generate and process cross-sectional images of patients.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K133589

Affected lot / code info

Model Number of device- 10742326  with serial numbers: 75514 75512 75510 75454 75437 75500 75475 75481 75439 75450 75482 75460 75493 75476 75458 75467 75487 75478 75513 75515, and  75501.

Why it was recalled

Software and firmware bugs

Root cause (FDA determination)

Software design

Action the firm took

Customers will be notified via the system interface and e-mail or U.S. postal mailing via a Customer Advisory Notice. If necessary the advisory letter may be hand delivered. The letter informed customers that the safety related issues identified were resolved by SW-Version VA50A_SP2. The update will be remotely pushed to affected systems. The letter also advised customers to notify anyone in their organization that should be aware of the information. In the event that the device had been sold, the notice should be forwarded to the new owner, and the firm should be informed of the new owner.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

40 Liberty Blvd, Malvern, Pennsylvania 19355-1418

Distribution

Distribution pattern

Nationwide Distribution

Timeline

Recall initiated

2015-08-18

Posted by FDA

2015-10-06

Terminated

2017-05-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #139933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.