# FDA recall Z-2496-2020

> **Tomtec Imaging Systems Gmbh** · Class II · device recall initiated 2019-09-23.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2496-2020
- **Recalling firm:** Tomtec Imaging Systems Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-09-23
- **Report date:** 2020-07-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Unterschleisheim, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2496-2020

## Citation

> AI Analytics. FDA recall Z-2496-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-2496-2020. Source: US FDA. Licensed CC0.

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