Recalls / —

—#45543

Product

SOMATOM CT System Sensation Open. Computed tomography x-ray system.

FDA product code

JAK — System, X-Ray, Tomography, Computed

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K040577

Affected lot / code info

Sensation Open model number 8872017 with serial numbers 49208, 49311, 49207, 49307 and 49330

Why it was recalled

When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern

Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.

Timeline

Recall initiated

2006-03-09

Posted by FDA

2006-04-26

Terminated

2006-07-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #45543. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.