Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2496-2020 — 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 p

U.S. FDA — Device Enforcement · Germany · 2019-09-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2496-2020
Date of alert: 2019-09-23
Country / jurisdiction: Germany
Risk level: Class II
Risk type: recall
Brand: Tomtec Imaging Systems Gmbh
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 04260361440143

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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