Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall TOMTECARENA TTA2

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall TOMTECARENA TTA2 see related information
Date Initiated by Firm September 23, 2019
Create Date July 04, 2020
Recall Status1 Open3, Classified
Recall Number Z-2496-2020
Recall Event ID 85392
510(K)Number K150122  
Product Classification System, image processing, radiological - Product Code LLZ
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
Code Information 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.
Recalling Firm/
Manufacturer		 Tomtec Imaging Systems Gmbh
Edisonstr. 6
Unterschleisheim Germany
For Additional Information Contact
855-4866832
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LLZ and Original Applicant = TOMTEC IMAGING SYSTEMS, GMBH
-
-