Recalls / —
—#35335
Product
SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73 93 114.
- FDA product code
- JAK — System, X-Ray, Tomography, Computed
- Device class
- Class 2
- Medical specialty
- Radiology
- 510(k) numbers
- K013522
- Affected lot / code info
- Serial Numbers: 51796, 51798, 51799, 51800, 51801, 51806, 51808, 51809, 51811, 51813, 51814, 51820, 51822, 51823, 51828, 51829, 51831, 51832, 51834, 51835, 51836, 51837, 51838, 51839, 51841, 51845, 51846, 51847, 51851, 51852, 51853, 51854, 51855, 51856, 51858, 51862, 51864, 51865, 51867, 51868, 51869, 51870, 51872, 51875, 51877, 51880, 51881, 51884, 51885, 51886, 51887, 51889, 51890, 51892, 51897, 51899, 51900, 51903, 51904, 51905, 51907, 51908, 51911, 51912, 51914, 51916, 51917, 51918, 51920, 51921, 51925, 51928, 51929, 51930, 51931, 51932, 51935, 51936, 51938, 51940, 51943, 51944, 51945, 51947, 51948, 51949, 51953, 51954, 51957, 51959, 51961, 51962, 51963, 51964, 51965, 51966, 51967, 51968, 51971, 51972, 51973, 51975, 51979, 51980, 51982, 51985, 51988, 51989, 51990, 51991, 51997, 51998, and 51999
Why it was recalled
Calcium Scoring feature on this devices is not closing properly after patient's exams.
Root cause (FDA determination)
Other
Action the firm took
The recalling firm issued a Customer Safety Advisory with Update Instructions, CT036/04/S and CN048.04/2 to their affected customers. The letter informed the customers of the potential issue and provided instructions to avoid the problem while using this feature. A software upgrade is being developed to corect this issue.
Recalling firm
- Firm
- Siemens Medical Solutions USA, Inc
- Address
- 51 Valley Stream Pkwy, Malvern, Pennsylvania 19355-1406
Distribution
- Distribution pattern
- The product was shipped to medical facilities nationwide and government account in IL.
Timeline
- Recall initiated
- 2004-09-28
- Posted by FDA
- 2004-11-03
- Terminated
- 2008-09-04
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #35335. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.