Class 2 Device Recall SOMATOM Sensation 16 ( Straton)

• Date Initiated by Firm: September 28, 2004
• Date Posted: November 03, 2004
• Recall Status: Terminated on September 04, 2008
• Recall Number: Z-0159-05
• Recall Event ID: 30173
• 510(K)Number: K013522
• Product Classification: System, X-Ray, Tomography, Computed - Product Code JAK
• Product: SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73 93 114.
• Code Information: 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
• Recalling Firm/ Manufacturer: Siemens Medical Solutions USA, Inc; 51 Valley Stream Pkwy; Malvern PA 19355-1406
• For Additional Information Contact: Roland Richter,; 610-448-1777
• Manufacturer Reason for Recall: Calcium Scoring feature on this devices is not closing properly after patient's exams.
• FDA Determined Cause: Other
• Action: 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.
• Quantity in Commerce: 113 units
• Distribution: The product was shipped to medical facilities nationwide and government account in IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JAK