FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
- Recall number
- Z-1095-04
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Image Navigator feature in the MagicView 300 VA42A or VA42B Software. Siemens Part Number: 7502003 and 8463163
- Status
- Terminated
- Initiated
- 2004-04-01
- Posted
- 2004-07-20
- Terminated
- 2004-09-21
- Reason
- Recalling firm became aware of a potential problem through the submission of a product complaint to the firm reporting the Image Navigator feature in the MagicView 300 VA42A or VA42B software are not being imported accurately to certain CT or MR images.
- Root cause
- Other
- Action
- The recalling firm has issued a letter to their Siemens Service Engineers to visit each affected sites, in order to correct the software problems. Additionally, a letter advising of the software problems was also sent to the Radiology Director at the affected sites, informing them of the 'Customer Safety Advisory' and the pending visit of the Seimens Service Engineers to perform a software update. Along with these letters, is a set of instructions detailing the potential risks and that a representative from the recalling firm will be contacting the medical facilities.
- Quantity
- not on file
- Distribution
- Nationwide. The product was shipped to various medical facilities, in the following states, AK, GA, FL, IA, MA, MI, MO, NH, NJ, NY, NV, OK, PA, TX, and WI.
- Lot, serial or model codes
- All software associated with Image Navigator feature in Magic View
- 510(k) numbers
- ["K935694"]
- 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