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Terminated

IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical imaging data. AGFA Corp., Greenville, South Carolina 2960.

FDA Recall Z-1306-2008 · Posted 2008-07-01

Recalling FirmAGFA Corp.
Recall StatusTerminated
Product CodeLMD
Date Initiated2007-12-11
Date Terminated2010-07-21
Product Quantity12 units

Reason for Recall

Failure of Data Transmission: No imaging data could be transmitted by the device, because a key value needed for data transmission was incorrectly entered in the affected units by AGFA Healthcare.

Firm Action

On 12/11/07, AGFA Healthcare sent out an e-mail to all affected consignees informing them of the situation. The firm also arranged to install the corrected License Key on all affected units of the product.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

Nationwide Distribution - USA, including states of CA, GA, IA and SD.

Official Source

View FDA Recall →

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

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