IMPAX 6.2.1 Network Gateway Server, License Key. Catalog # ABC code: EXEGE000. The product is used to transfer medical i
FDA device recall Z-1306-2008 · posted 2008-07-01 · Terminated
Recall details
- Recalling firm
- AGFA Corp.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LMD
- Quantity affected
- 12 units
- Distribution
- Nationwide Distribution - USA, including states of CA, GA, IA and SD.
- Date initiated
- 2007-12-11
- Date posted
- 2008-07-01
- Date terminated
- 2010-07-21
- Location
- Greenville, SC
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