FDA Medical Device Recalls (openFDA)
General Electric Medical Systems Information Technology: Solar 9500 Information Monitor with software version 3A.
- Recall number
- Z-0250-04
- Recalling firm
- General Electric Medical Systems Information Technology
- Product
- Solar 9500 Information Monitor with software version 3A.
- Status
- Terminated
- Initiated
- 2003-11-10
- Posted
- 2003-12-18
- Terminated
- 2005-11-23
- Reason
- Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
- Root cause
- Other
- Action
- A letter dated November 10, 2003 was sent to the consignees. The letter recommended certain actions to avoid the problems and provided options for the software to be updated.
- Quantity
- maximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software update kits to update multiple)
- Distribution
- The product was distributed to consignees located nationwide in the United States and worldwide.
- Lot, serial or model codes
- Solar 9500 Information Monitor with software version 3A.
- 510(k) numbers
- ["K030575"]
- PMA numbers
- not on file
- Product code
- MHX
- Firm FEI
- 2124823
- Firm city
- Milwaukee
- Firm state
- WI
- 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