FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Emotion 6 (Model 10165888)
- Recall number
- Z-2472-2018
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Emotion 6 (Model 10165888)
- Status
- Terminated
- Initiated
- 2018-02-01
- Posted
- 2018-03-30
- Terminated
- 2020-05-01
- Reason
- A potential risk of unnecessary radiation exposure due to a software issue
- Root cause
- Software design
- Action
- Customers were sent notification letter via USPS with Certified Mail Receipts and Electronic Receipts.
- Quantity
- not on file
- Distribution
- Nationwide
- Lot, serial or model codes
- Serial No. 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888 10165888
- 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