—#27287

Product

Leonardo Workstations with software version 2022A/B, 2003A

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010938
Affected lot / code info: Model 7129534, Serial # 01001 through 01380, 05001 through 05600, and 10001 through 10320

Why it was recalled

software problem This error may cause the loss of peripheral image information when there is a difference between the dimensions of the image matrix and the display segment.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued three separate customer advisory letters dated 2/28/03, 03/01/03, and 4/14/03 to their customers explaining the problem and the preventive measure to avoid loss of information.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Parkway, Malvern, Pennsylvania 19355

Distribution

Distribution pattern: The product was shipped to distributors, medical facilities and Siemens training facilities nationwide.

Timeline

Recall initiated: 2003-02-28
Posted by FDA: 2003-08-07
Terminated: 2004-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #27287. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.