🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: September 23, 2019 Tomtec Imaging Systems Gmbh Infusion Pumps

What Should You Do?

  1. Check if you have this product:
    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.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Tomtec Imaging Systems Gmbh
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 Codes/Lot Numbers:

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.

Distribution:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2496-2020