—#85876

Product

Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K082430
Affected lot / code info: Model number 10496279 - Serial numbers: 1088, 1089, 1150, 1165, 1166, 1213, 1214, 1344, 1361, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1395, 1413, 1418, 1424, 1425, 1453, 1496, and 1497.

Why it was recalled

Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.

Recalling firm

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

Distribution

Distribution pattern: The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.

Timeline

Recall initiated: 2009-09-29
Posted by FDA: 2009-11-16
Terminated: 2012-07-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #85876. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.