DR 800 SYSTEM, X-RAY, TOMOGRAPHIC

Description of Event or Problem

THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO PROVIDE THE ROOT CAUSE AND ACTIONS TAKEN. SEE H10 FOR ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

AFTER FURTHER INVESTIGATION BY AGFA, THE ROOT CAUSE WAS CONFIRMED, IN VERY RARE CASES, A DIGITAL TOMOSYNTHESIS (DTS). SEQUENCE DOES NOT STOP AUTOMATICALLY. TYPICALLY, IT CAN BE REPRODUCED AT LOW NON CLINICAL RELEVANT EXPOSURE VALUES (0.1 AND 0.2 MAS). NO RETAKE IS REQUIRED, HOWEVER THE DTS SEQUENCE CANNOT BE ARCHIVED. ADDITIONAL REPORTING FOR THIS EVENT AND ACTIONS TAKEN WERE REPORTED TO FDA VIA 21 CFR 806 ON FEBRUARY 10, 2020. MARCH 6, 2020, AGFA WAS CONTACTED BY CDRH CONFIRMING ALTHOUGH AGFA FILED A REPORT ACCORDING TO 21 CFR 806 . (MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS), THE PROBLEM AND ITS CORRECTION WOULD BE MORE APPROPRIATELY HANDLED THROUGH THE PROCESSES PRESCRIBED BY 21 CFR SUBCHAPTERJ. AGFA COMPLIED AND PROVIDED ADDITONAL INFORMATION IN ACCORDANCE WITH CFR 1003 (NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY) AND 21 CFR 1004 (REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS) TO CDRH ON MARCH 10, 2020. MARCH 18, 2020, CDRH APPROVED AGFA'S CORRECTIVE ACTION PLAN (CAP) AND CLASSIFIED AGFA'S ACTION AS A CLASS II RECALL. THE RECALL WAS ASSIGNED Z-1502-2020. AGFA HAS CONCLUDED THIS RECALL CORRECTION ACTIVITY AND HAS PROVIDED A FORMAL REQUEST FOR CLOSURE OF THIS RECALL RECORD TO FDA FEBRUARY 15, 2021.

Description of Event or Problem

A CUSTOMER IN GERMANY REPORTED TO AGFA, WHILE USING THE DR 800 SYSTEM, A PROBLEM WITH THE TOMOSYNTHESIS SEQUENCE. THE CUSTOMER REPORTED THE DR 800 TOMOSYNTHESIS SEQUENCE STARTED NORMALLY, BUT WHEN THE SYSTEM REACHED THE END POSITION, THE EXPOSURES DID NOT STOP. THE SYSTEM OPERATOR MANUALLY INTERRUPTED THE SEQUENCE. THE OPERATOR ALSO REPORTED THE SEQUENCE WOULD NOT ARCHIVE. INVESTIGATION AND CORRECTIVE ACTION PLANNING IS UNDERWAY WITH THE SUPPLIER AND AGFA. A SUPPLEMENTAL REPORT WILL BE PROVIDED.