FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens syngo Imaging XS. Radiological image processing system.
- Recall number
- Z-1064-2012
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens syngo Imaging XS. Radiological image processing system.
- Status
- Terminated
- Initiated
- 2012-01-26
- Posted
- 2012-02-20
- Terminated
- 2012-09-29
- Reason
- In September 2011 firm issued two Customer Safety Advisory Notices for syngo Imaging XS. Firm became aware of an unintended behavior when using syngo Imaging XS, version VA70A and VA70B with Client/Server Installations. Loading additional images/series from the Patient Browser using the thumbnails may cause unintended deletion of images/series. In response, firm issued a Customer Safety Advisor
- Root cause
- Software design
- Action
- Siemens Medical issued an "UPDATE INSTRUCTIONS SY055/11/S/UPDATE PACKAGE VA70B_0211" to all affected customers. The package described the product, problem, and instructions for customers to follow.
- Quantity
- 128
- Distribution
- Nationwide Distribution-including the states of CA, CO, CT, FL, GA, IL, IN, IA, KS, MD, MN, MO, NE, NV, NJ, NY, NC, OH, PA, TN, TX, and WI.
- Lot, serial or model codes
- Model number 10496279 -- serial numbers 1344, 1744, 1187, 2981, 1361, 3052, 3053, 3054, 3055, 3056, 3057, 3058, 3059, 3060, 3061, 2323, 2254, 1088, 1089, 2194, 2195, 1213, 1214, 1188, 1189, 3086, 2626, 1828, 1624, 1625, 2878, 2365, 2366, 3087, 3088, 3089, 2500, 2971, 1424, 1425, 3093, 2890, 1371, 1372, 3062, 2267, 2268, 2269, 1856, 1857, 2695, 2696, 3010, 1373, 1374, 1375, 1376, 1377, 1713, 1712, 2408, 2409, 2559, 2560, 2561, 2562, 1735, 1668, 2098, 1190, 1418, 2069, 2698, 2769, 1884, 1381, 1382, 1378, 1379, 1380, 1165, 2310, 2311, 2312, 2448, 2449, 2450, 2670, 2671, 2672, 2673, 2674, 2675, 2676, 2677, 2678, 2679, 2324, 1940, 1395, 2901, 2897, 2898, 2899, 2900, 2934, 3017, 2144, 2145, 2146, 2147, 2148, 2149, 2150, 2151, 2152, 2153, 2154, 2155, 2156, 2157, 2158, 2159, 2200, 2201, 1383, 3050, and 3085.
- 510(k) numbers
- ["K082430"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28