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Terminated

Solar 9500 Information Monitor with software version 3A.

FDA Recall Z-0250-04 · Posted 2003-12-18

Recalling FirmGeneral Electric Medical Systems Information Technology
Recall StatusTerminated
Product CodeMHX
Date Initiated2003-11-10
Date Terminated2005-11-23
Product Quantitymaximum 648 Solar 9500s with Version 3A software (297 Solar 9500 Vers. 3A software were manufactured plus 131 software update kits to update multiple)

Reason for Recall

Software gives inaccurate readings when transferring TRAM module from Solar 9500 to other Solar monitoring systems without discharging TRAM first.

Firm 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.

Root Cause

Other

Distribution Pattern

The product was distributed to consignees located nationwide in the United States and worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030575MODIFICATION TO SOLAR 9500 INFORMATION MONITORGe Medical Systems Information Technologies · 2003-03-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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