AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a Tomographic X-ray system - Product Usage: TomoSynthesis is used to synthesize tomographic slices from a single tomographic sweep. The DR 800 is not intended for mammography applications
FDA Recall Z-1502-2020 · Posted None
Recalling FirmAgfa N.V.
Recall StatusTerminated
Product CodeIZF
Date Initiated2020-02-10
Date Terminated2023-03-30
Product Quantity2 units
Reason for Recall
Tomosynthesis image acquisition sequence did not stop automatically after expected number of exposures.
Firm Action
AFGA issued via email On February 10, 2020, an URGENT FIELD SAFETY NOTICE letter. Letter states reason for recall, health risk, and action to take:
With this letter, Agfa is informing you that the DR 800 system still can be used including for Tomosynthesis for mAs values which are larger than 0,2 mAs.
In case Tomosynthesis image acquisition sequence does not stop automatically after the expected number of exposures, release the exposure button as this will stop the sequence and notify your Agfa Service contact at once.
Contact your local Agfa Imaging organization 1-877-777-2432 and please reference Problem Record PRB2000387 and Vigilance Record VR0000716.
Complete/Return by fax or email the URGENT FIELD SAFETY NOTICE Feedback form
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution in the states of FL, VA.
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.