Solar 9500 Information Monitor with software version 3A.
FDA device recall Z-0250-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- General Electric Medical Systems Information Technology
- Reason for recall
- Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MHX
- Quantity affected
- 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.
- Date initiated
- 2003-11-10
- Date posted
- 2003-12-18
- Date terminated
- 2005-11-23
- Location
- Milwaukee, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO SOLAR 9500 INFORMATION MONITOR (K030575) | Ge Medical Systems Information Technologies | 2003-03-21 |