—#74696

Product

syngo MultiModality WorkPlace (MM WP). Software product(Model Number 10140720). The product is intended for use in picture archiving and communications system.

FDA product code: LLZ — System, Image Processing, Radiological
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K010938
Affected lot / code info: Serial numbers: 7826, 7951, 7981, 7989, 8011, 8056, 8109, 8161, 8209, 8213, 8312, 8341, 8361, 8382, 8393, 8405, 8409, 8413, 8430, 8433, 8442, 8511, 8526, 8536, 8548, 8637, 8638, 8657, 8670, 8688, 8701, 8707, 8771, 8772, 8773, 8774, 8781, 8793, 8814, 8829, 8862, 8879, 8881, 9043, 9044, 9046, 9080, 9097, 9081, 9105, 9137, 9149, 9152, 9154, 9188, 9191, 9206, 9218, 9219, 9232, 9235, 9243, 9244, 9248, 9283, 9291, 9316, 9322, 9351, 9360, 9361, 9368, 9388, 9394, 9395, 9413, 9414, 9416, 9417, 9429, 9445, 9446, 9452, 9488, 9498, 9504, 9508, 9520, 9521, 9532, 9536, 9568, 9723, 9725, 9729, 9737, 15154, 15510, 15512, 20903, 20904, 20907, 20917, 20928, 20931, 20937, 20939, 20940, 20941, 20942, 20943, 20944, 20945, 20946, 20948, 20955, 20956, 20957, 20961, 20962, 20972, 20974, 20977, 21017, 21018, 21020, 21021, 21025, 21028, and 21030.

Why it was recalled

Values derived from Dynamic CT data sets may be incorrect. The corresponding images are not affected.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm has issued a software update to affected customers via Update Instructions CT034/08/S. This software update corrects the values from the volume perfusion post processing application. A firm representative will visit each consignee to install the software update beginning 9/12/08.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc
Address: 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406

Distribution

Distribution pattern: Nationwide Distribution.

Timeline

Recall initiated: 2008-09-12
Posted by FDA: 2008-12-03
Terminated: 2009-09-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #74696. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.