TOMTEC-ARENA TTA2 — Class II medical device recall Z-2496-2020
Ongoing recall by Tomtec Imaging Systems Gmbh, reported 2020-07-15, distributed in AL, AZ, CA, CT, IL, MA, MI, NC…. The firm discovered a software issue associated with the Image-Com module/clinical application package (CAP) i
| Recall number | Z-2496-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tomtec Imaging Systems Gmbh, Unterschleisheim, Germany |
| Recall initiated | 2019-09-23 |
| Classified | 2020-07-04 |
| Reported by FDA | 2020-07-15 |
| Distributed | AL, AZ, CA, CT, IL, MA, MI, NC, NJ, NY, OH, PA, RI, TX, VA |
| Countries outside the US | AU, CA, CH, CZ, DE, FR, GB, IT, LV, SE |
| Quantity | 62 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04260361440143 |
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
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.