| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-06-26 | 0 |
Patient 1
WE RECEIVED NOTIFICATION FROM OUR CUSTOMER THAT OUR SECONDLOOK, COMPUTER-AIDED DETECTION (CAD) SYSTEM FOR MAMMOGRAPHY HAD ALLEGEDLY MALFUNCTIONED. THE CUSTOMER REPORTED THAT THE ICAD SYSTEM IMAGES WERE BEING SENT TO A (B)(4) WORKSTATION THAT APPEARED SLIGHTLY SKEWED IN THE STRUCTURED WORKSTATION REPORT. THE CUSTOMER INDICATED THAT THIS EVENT OCCURRED AFTER HOLOGIC UPGRADED THEIR WORKSTATION SOFTWARE. (B)(4).
Patient 1
ICAD RECEIVED INFORMATION FROM THE CUSTOMER INDICATING THAT (B)(4) HAD IDENTIFIED THAT THE PROBLEM WAS BEING CAUSED BY THEIR DEVICE. ICAD CONTACTED (B)(4) FOR MORE INFORMATION ON THIS ISSUE. OUR INVESTIGATION HAS IDENTIFIED THE ROOT CAUSE OF THE REPORTED CONDITION AS A SOFTWARE ERROR USED IN THE (B)(4) WORKSTATION THAT RESULTED IN THE SKEWED CAD MARKS OUR CUSTOMER REPORTED TO ICAD. ON (B)(4) 2008, ICAD BECAME AWARE OF A CLASS 3 RECALL ON THE (B)(4) FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THIS SYSTEM WAS IDENTIFIED BY OUR CUSTOMER AS BEING USED WITH THE ICAD SECONDLOOK DIGITAL SERVER IN THE (B)(6) 2008 REPORTED EVENT. ICAD CONTACTED (B)(4) TO DETERMINE IF THE CORRECTIVE ACTIONS IDENTIFIED IN THE (B)(4) RECALL NOTIFICATION HAD TAKEN PLACE. THE (B)(4) REPRESENTATIVE INDICATED THAT THE WORKSTATION SERIAL NUMBERS LISTED ON THE RECALL WERE BEING CORRECTED. ICAD MADE A FOLLOW-UP PHONE CALL TO OUR CUSTOMER TO CHECK THE STATUS OF THE (B)(4) RECALL ACTIONS. OUR CUSTOMER REPORTED THAT AFTER (B)(4) CORRECTED THE REPORTED SOFTWARE ISSUE, THE PROBLEM HAD NOT REOCCURRED. NO ADDITIONAL ACTIONS ARE PLANNED BY ICAD HOWEVER, WE WILL CONTINUE TO MONITOR FOR THE REPORTED CONDITION.