FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Emotion 16. Computed tomography X-ray system
- Recall number
- Z-2453-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Emotion 16. Computed tomography X-ray system
- Status
- Terminated
- Initiated
- 2008-08-05
- Posted
- 2008-09-21
- Terminated
- 2008-11-07
- Reason
- Potential electrical shock hazard. The LCB power Switch (S1) could break causing the protective plastic cap to come off exposing the energized electrical contacts within the switch. The LCB S1 does have an inline fuse which is designed to open in the event of a short circuit condition between the internal switch contacts.
- Root cause
- Nonconforming Material/Component
- Action
- The firm issued and Safety Update in July 2008 informing users that the firm will have representatives visit each account to replace the cap per Update Instructions CT032/08/S.
- Quantity
- 53 units
- Distribution
- Nationwide including states of AK, AL, CO, FL, GA, IA, ID, IL, IN, LA, MD, MN, MS, NC, NE, NY, OH, OK, OR, RI, SD, TX, UT, WA, and WI.
- Lot, serial or model codes
- Model Numbers: 10165888, 10165977, and 10046789.
- 510(k) numbers
- ["K050297"]
- 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