FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
- Recall number
- Z-0270-2010
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Syngo Imaging XS VA60 and VA70 in combination with JPEG Compression.
- Status
- Terminated
- Initiated
- 2009-09-29
- Posted
- 2009-11-16
- Terminated
- 2012-07-05
- Reason
- Distorted image. The "Distorted" image cannot be used for diagnostic findings, and, depending on the customer scenario, a repeated exam could be necessary if the image cannot be reported on any other workplace or recovered from another source.
- Root cause
- Software design
- Action
- The recalling firm issued a Customer Safety Advisory notice dated 9/14/09 to all affected customers via Update Instructions IM100/09/S. The notice informs the customer of the potential issue and provides instructions to avoid its occurrence. To avoid the potential risk of the issue, the local compression function can be disabled as described in the letter. Depending on the image data, the disabling of compression will result in increased storage usage. The issue will be resolved in the release of version VA70B. For all potentially affected customers with "JPEG Compression" license an update instruction will be released which defines the necessary corrective actions in case of "Distorted" images. The update instruction will be performed on request by the customer service group. Further questions regarding this issue are directed to the local SIEMENS Uptime Service Center or +49 (9131) 84-2056.
- Quantity
- 28 units
- Distribution
- The product was shipped to medical facilities in CA, FL, GA, IL, MD, MI, MO, NE, NC, NY, OH, PA, TN, TX, and WV.
- Lot, serial or model codes
- Model number 7502029 - Serial numbers: 9620, 9621, 9622, 9623, 9624, 9625, 9630, 9631, 9632, 9633, 9634, 9639, 9640, 12068, 12271, 13090, 13358, 13428, 13480, 13637, 13727, 13742, 13945, 13971, 13979, 14059, 14086, and 14960.
- 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