Atlas FDA

Digital Radiography System, model DFP-8000D

FDA device recall Z-1337-04 · posted 2004-08-11 · Terminated

Recall details

Recalling firm
Toshiba American Med Sys Inc
Reason for recall
Defect in the mirroring unit.
Action taken
An advisory letter will be sent to all users 6/24/2004. An order was issued to correct the firmware problem.
Root cause
Other
Status
Terminated
Product code
JAA
Quantity affected
19
Distribution
Nationwide.
Date initiated
2004-06-18
Date posted
2004-08-11
Date terminated
2005-03-15
Location
Tustin, CA

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Related 510(k) clearances

RecordFirmDate
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D (K013608)Toshiba America Medical Systems, In.C2001-11-15