Z-2496-2020Class II

TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software...

Name: Z-2496-2020 TOMTEC-ARENA TTA2;software version no. 2.20 and lower; Picture archiving and communications system. Software...
Creator: Tomtec Imaging Systems Gmbh
Published: 2019-09-23
License: https://open.fda.gov/license/

TOMTEC Imaging Systems GmbH / initiated 2019-09-23 / Open, Classified / root cause: software

FDA source

Tomtec Imaging Systems Gmbh began a recall of 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... on 2019-09-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2496-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-23
Posted: 2020-07-04
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
Product code: LLZ System, Image Processing, Radiological
Reason for recall: 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 tag: software
FDA 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 [email protected]. 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2496-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2496-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-07-15	2020-07-04

Product code LLZ

K150122Class IITomtec-Arena Tta2Tomtec Imaging Systems GmbH / cleared 2015-02-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)