Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
TOMTEC-ARENA TTA2 Recalled by Tomtec Imaging Systems Gmbh Due to The firm discovered a software issue associated with...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Tomtec Imaging Systems Gmbh directly.
Affected Products
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
Quantity: 62 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 15 states: AL, AZ, CA, CT, IL, MA, MI, NJ, NY, NC, OH, PA, RI, TX, VA
About Tomtec Imaging Systems Gmbh
Tomtec Imaging Systems Gmbh has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report