| Class 2 Device Recall TOMTECARENA TTA2 | |
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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = LLZ
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