FDA Medical Device Recalls (openFDA)
Siemens Medical Systems Inc: Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +
- Recall number
- Z-0322-03
- Recalling firm
- Siemens Medical Systems Inc
- Product
- Computed Tomography system, Diagnostic Imaging: Somatom Sensation 4 Somatom Volume Zoom Somatom Volume Access Somatom Balance Somatom Emotion Somatom Emotion Duo Somatom Esprit Somatom Esprit +
- Status
- Terminated
- Initiated
- 2002-07-10
- Posted
- 2002-12-05
- Terminated
- 2003-03-24
- Reason
- Head holder cannot be properly secured on the table top.
- Root cause
- Other
- Action
- Siemens sent all customers a Update Instruction CT016/02/S document alerting them to the problem. This is their recall notification.
- Quantity
- 250
- Distribution
- The firm distributed 75 units to 74 hospitals/clinics throughout the United States. US government accounts are 14. 175 units were distributed to 45 different countries worldwide.
- Lot, serial or model codes
- Somatom Sensation 4 -- Serial Numbers 28001 to 28070 Somatom Volume Zoom -- Serial Numbers 24006 to 24752 Somatom Volume Access -- Serial Numbers 26111 to 26123 Somatom Valance -- Serial Numbers 38169 to 38475 Somatom Emotion -- Serial Numbers 40354 to 40383 Somatom Emotion Duo -- Serial Numbers 36081 to 36126 Somatom Esprit -- Serial Numbers 34191 to 34213 Somatom Esprit+ -- Serial Numbers 35024 to 35039
- 510(k) numbers
- ["K013522"]
- PMA numbers
- not on file
- Product code
- JAK
- Firm FEI
- not on file
- Firm city
- So Iselin
- Firm state
- NJ
- 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