FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
- Recall number
- Z-0732-2008
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Siemens Syngo Imaging System with VB30A version of software. Model Number: 10014063, Siemans Medical Solutions, Malvern, PA 19355
- Status
- Terminated
- Initiated
- 2007-11-27
- Posted
- 2008-02-23
- Terminated
- 2008-09-17
- Reason
- Inconsistent data - A buffer overflow may occur between information system and picture system if the system experiences a high load. (e.g. RIS/PACS communication is unusally high)
- Root cause
- Software design
- Action
- The recalling firm issued a Customer Safety Advisory, via certified mail. to the affected customers on 11/27/07. The letter informs the customer of the issue and also provides instruction to detect and avoid its occurrence. In addition, the firm is developing a software update to correct the issue, which will be installed on the affected systems when it is released.
- Quantity
- 10 units
- Distribution
- Nationwide Distribution, including states of AL, MO, NC, NY, OH, OR, TN, and TX.
- Lot, serial or model codes
- Serial Numbers: 1005, 1065, 1076, 1112, 1202, 1242, 1269, 1278, 1279, and 1282.
- 510(k) numbers
- ["K071114"]
- 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