FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.
- Recall number
- Z-0795-06
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM CT System Sensation 40 and Sensation 64. Computed tomography x-ray system.
- Status
- Terminated
- Initiated
- 2006-03-09
- Posted
- 2006-04-26
- Terminated
- 2006-07-19
- Reason
- When using the LungCare feature in the SOMATOM CT Systems some marks made on CT images may not be saved.
- Root cause
- Other
- Action
- The recalling firm has issued a software patch to the affected customers per Update Instructions CT086/05/S and CT087/05/S. By letter 3/9/2006. In addition, a Siemens Service Engineer will visit affected sites to install this software patch which will resolve this issue.
- Quantity
- 38 units
- Distribution
- Nationwide. The product was shipped to AK, AZ, CA, DE, FL, GA, IL, IN, KY, LA, MD, ME, MI, MT, NC, NY, OH, OK, PA, PR, TX, UT, VA, WA and WI.
- Lot, serial or model codes
- Sensation 40 model number 8874427 with serial numbers 57021, 57028, 57015, 57037, 57001, 57038, 57019 and Sensation 64 model number 8377520 with serial numbers 54219, 54508, 54060, 54436, 54482, 54437, 54188, 54407, 54154, 54051, 54422, 54530, 54528, 54056, 54445, 54480, 54489, 54556, 54560, 54418, 54463, 54016, 54534, 54404, 54064, 54488, 54269, 54416, 54529, 54305 and 54210
- 510(k) numbers
- ["K040665"]
- 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