Recalls / —

—#73623

Product

Syngo Imaging with versions VB20B, VB20D, VB20F, VB20G, VB25B, VB30A, VB30A_SP1, and VB30A_SP2.

FDA product code

LLZ — System, Image Processing, Radiological

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K052461, K071114

Affected lot / code info

Model number 10014063. Serial numbers: 1005, 1039, 1040, 1041, 1049, 1053, 1055, 1056, 1057, 1058, 1061, 1064, 1065, 1067, 1071, 1074, 1076, 1079, 1080, 1081, 1082, 1083, 1084, 1086, 1089, 1090, 1095, 1105, 1107, 1112, 1116, 1119, 1124, 1174, 1188, 1198, 1202, 1203, 1210, 1218, 1226, 1227, 1229, 1240, 1246, 1247, 1258, 1269, 1271, 1278, 1279, 1282, 1316, 1322, 1329, 1334, 1343, 1351, and 1353.

Why it was recalled

Image may not be visible after merge.

Root cause (FDA determination)

Software design

Action the firm took

The recalling firm issued Customer Safety Advisory Notice dated 8/22/08 to inform the consignees of the potential issue and provide instruction to avoid its occurrence. To avoid potential risk of this issue, users are asked to check whether the extended HL7 messages as stated in the letter are mandatory for their RIS-PACS workflow, and disable these messages if they are not. Siemens is preparing a modification under the UI IM086/08/S for the affected versions of syngo Imaging that will resolve the potential malfunction. The field modification will be immediately distributed and installed by the firm's Service as soon as it is available.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide Distribution --- including states of AL, AZ, CA, CO, CT, FL, IA, KS, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, TN, TX, and WI.

Timeline

Recall initiated

2008-08-22

Posted by FDA

2008-10-15

Terminated

2008-11-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #73623. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.