FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73 93 114.
- Recall number
- Z-0159-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM CT System Sensation 16 (+ Straton), Computed Tomography System, Model Number 73 93 114.
- Status
- Terminated
- Initiated
- 2004-09-28
- Posted
- 2004-11-03
- Terminated
- 2008-09-04
- Reason
- Calcium Scoring feature on this devices is not closing properly after patient's exams.
- Root 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
- 113 units
- Distribution
- The product was shipped to medical facilities nationwide and government account in IL.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K013522"]
- PMA numbers
- not on file
- Product code
- JAK
- 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