Recalls / —

—#73302

Product

Bicor Hi-P X-Ray System, Model numbers 6379767 and 6258383.

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K940484

Affected lot / code info

Model number 6379767 - Serial numbers: 2002, 2004, 2005, 2011, 2012, 2015, 2016, 2017, 2018, 2022, 2025, 2026, 2033, 2042, 2045, 2055, 2058, 2059, 2063, 2066, 2070, 2072, 2078, 2083, 2089, 2092, 2093, 2094, 2096, 2097, 2098, 2099, and 2101. Model number 6258383: Serial numbers: 1014, 1015, 1034, 1044, 1045, 1050, 1054, 1061, 1067, 1073, 1090, 1091, 1099, 1101, 1102, 1103, 1109, 1115, 1122, 1126, 1128, 1132, 1133, 1137, 1138, 1141, 1142, 1143, 1147, 1152, 1156, 1157, and 1162.

Why it was recalled

Unintended movement of the system table and/or C arm.

Root cause (FDA determination)

Software design

Action the firm took

Siemens Medical Solutions issued a letter to consignees on 8/11/2008 to inform them of the problem and a workaround should the issue occur prior to software revision.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

51 Valley Stream Pkwy, Malvern, Pennsylvania 19355

Distribution

Distribution pattern

Nationwide.

Timeline

Recall initiated

2008-08-11

Posted by FDA

2008-11-04

Terminated

2012-12-21

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #73302. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.