FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM CT System Emotion 6, Computed Tomography X-Ray System, Model Number: 38 15 490
- Recall number
- Z-0157-05
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM CT System Emotion 6, Computed Tomography X-Ray System, Model Number: 38 15 490
- 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
- 29 units
- Distribution
- The product was shipped to medical facilities nationwide and government account in IL.
- Lot, serial or model codes
- Serial Numbers: 43007, 43014, 43015, 43020, 43024, 43031, 43032, 43052, 43053, 43097, 43098, 43114, 43199, 43218, 43222, 43228, 43244, 43258, 43269, 43273, 43287, 43298, 43308, 43329, 43343, 43346, 43347, 43349, and 43361.
- 510(k) numbers
- ["K023687"]
- 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