FDA Medical Device Recalls (openFDA)
Tomtec Imaging Systems Gmbh: 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)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18
- Recall number
- Z-2496-2020
- Recalling firm
- Tomtec Imaging Systems Gmbh
- Product
- 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)04260361440143(11)161028(10)20.14 TTA2.20.15 UDI: (01)04260361440143[11]161207[10]20.15 TTA2.20.16 UDI:(01)04260361440143(11)170127(10)20.16 TTA2.20.18 UDI:(01)04260361440143(11)170622(10)20.18
- Status
- Open, Classified
- Initiated
- 2019-09-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Software design
- Action
- 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
- Quantity
- 62 units
- Distribution
- US:AL, AZ, CA, CT, IL, MA, MI,NC, NJ, NY, OH, PA, RI, TX, VA. OUS: Australia, Canada, Czech Republic, France, Germany, Italy, Latvia, Sweden, Switzerland, United Kingdom.
- Lot, serial or model codes
- The affected product versions are TOMTEC-ARENA, TTA 2.20 and lower, with modules 4D LV-Analysis, 4D RV-Function, 4D MV-Assessment, 3D Cardio-View, 4D Sono-Scan, Echo-Com, 2D Cardiac Performance Analysis, and QAngio.
- 510(k) numbers
- ["K150122"]
- PMA numbers
- not on file
- Product code
- LLZ
- Firm FEI
- 1000185293
- Firm city
- Unterschleisheim
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28