FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Recall number
- Z-1646-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
- Status
- Terminated
- Initiated
- 2015-04-20
- Posted
- 2015-05-22
- Terminated
- 2016-09-01
- Reason
- Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
- Root cause
- Software design
- Action
- Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.
- Quantity
- 75
- Distribution
- Nationwide Distribution including Puerto Rico.
- Lot, serial or model codes
- SOMATOM Perspective - 10495568 with serial numbers: 59019 59195 59060 59043 59025 59029 59189 59204 76954 59010 59164 59185 59048 59169 77107 77110 59011 59030 59171 59168 59017 59167 59162 59190 59047 59061 77121 59028 59165 59020 59181 59037 59035 59005 59183 59016 59027 59184 76950 59203 59015 77182
- 510(k) numbers
- ["K133590"]
- 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