FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo Imaging XS model number 10496279 The intended use: image processing radiological
- Recall number
- Z-1423-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo Imaging XS model number 10496279 The intended use: image processing radiological
- Status
- Terminated
- Initiated
- 2010-02-16
- Posted
- 2010-04-20
- Terminated
- 2012-07-05
- Reason
- images can be overwritten
- Root cause
- Software design
- Action
- A "Customer (Safety) Advisory notice" dated February 16, 2010, was sent all affected customers via Update Instructions IM019/10/S. This notice describes the product, problem and the action to be taken by the customers. The customers should immediately instruct their employees of the advisor notice and maintain awareness. If the customer sold the device/equipment and is no longer in possession of it, they should forward the notice and inform Siemens of the new owner. A software update to correct this issue will be distributed and installed by a Siemens Service Engineer on all affected systems under Update Instructions IM020/10/S. If you have any further questions regarding this issue, do not hesitate to contact your local SIEMENS Uptime Service Center (michael.mib.braun@siemens.com).
- Quantity
- 6 units
- Distribution
- Nationwide distribution: CA, NC, NY, PA, and TX
- Lot, serial or model codes
- Model number 10496279. Serial numbers: 1165, 1213, 1361, 1373, 1395, and 1424.
- 510(k) numbers
- ["K082430"]
- PMA numbers
- not on file
- Product code
- LLZ
- 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