Recall Z-1306-2008 ยท LMD System, Digital Image Communications, Radiological
AGFA Corp.
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.
| Date | Jul 1, 2008 (initiated Dec 11, 2007) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Release of Material/Component prior to receiving test results |
| 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. |
| Quantity | 12 units |
| Distribution | Nationwide Distribution - USA, including states of CA, GA, IA and SD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.