Tomtec Imaging Systems Gmbh Edisonstr. 6 Unterschleisheim Germany TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software Versions and applicable UDI: TTA 1.2 release prior to UDI requirement TTA2.00.01 release prior to UDI requirement TTA2.11.01 release prior to UDI requirement TTA2.11.02 release prior to UDI requirement TTA2.20.01 UDI: (01)04260361440143(11)160429(10)20.01 TTA2.20.10 UDI:(01)04260361440143(11)160809(10)20.10 TTA2.20.13 UDI:(01)04260361440143(11)160922(10)20.13 TTA2.20.14 UDI:(01)04260361 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) interface for 3D application in the ARENA software, where measurements from one study might be stored to another study.

Recommended Action

Per FDA guidance

Customers were sent the Urgent Medical Device Correction, Field Safety Notice letters, issued on 09/23/2019 via certified mail (USPS) with return receipt. The firm asked customers to follow the Action to be Taken by Customer/User section of the Urgent Medical Device Correction Letter. The instructions describe how to delete all measurements if a Clinical Application Package (CAP) has been initiated and the clip/image is rejected. The instructions to the customers to avoid the software issue are as follows: If a CAP has been initiated and the clip/image is rejected and one of the messages described under problem description is displayed, take the following actions: 1. Close the message dialog from the CAP and move back to IMAGE-COM 2. Press the Worksheet Button 3. Navigate through the measurements menu and check all packages (4D LVA, 4D MVA, 4D RVF, 2D CPA, 4D CV) in all groups in the exam types Adult Echo and Pediatric echo. Definition of hierarchy: -Exam Type (e.g. Adult Echo, Pediatric Echo, ...) Group (eg: Left Ventricle, Mitral Valve, Right Ventricle, Left Ventricle) - Package (e.g.: 4D LVA, 4D MVA, 4D RVF, 2D CPA, 4D CV) - SubPackage (optional) o Measurement 4. Once found, delete all measurements on the above described packages by using the available delete functions. 5. All packages described above in the worksheet shall be completely empty. 6. Once finished, close the Worksheet. If you suspect that the patient data software issue has occurred, contact the local representative for support. Complete the reply form and return as soon as possible via email to support@tomtecusa.com. The firm will resolve the issue by providing a software update, at no cost, to correct the issue in the software version that is currently installed on your system. A representative will contact to schedule the software installation. If further information or support is needed concerning this issue, contact the local representative at

Distribution

As reported by FDA

AL, AZ, CA, CT, IL, MA, MI, NJ, NY, NC, OH, PA, RI, TX, VA