Digital Radiography System, model DFP-8000D
FDA Recall Z-1337-04 · Posted 2004-08-11
Recalling FirmToshiba American Med Sys Inc
Recall StatusTerminated
Product CodeJAA
Date Initiated2004-06-18
Date Terminated2005-03-15
Product Quantity19
Reason for Recall
Defect in the mirroring unit.
Firm Action
An advisory letter will be sent to all users 6/24/2004. An order was issued to correct the firmware problem.
Root Cause
Other
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.